[{"id":13604,"date":"2024-12-13T11:55:54","date_gmt":"2024-12-13T11:55:54","guid":{"rendered":"https:\/\/neuronewsinternational.com\/?p=13604"},"modified":"2024-12-13T11:55:54","modified_gmt":"2024-12-13T11:55:54","slug":"endovascular-treatment-of-brain-aneurysms-is-under-5mm-a-go-or-no-go-area","status":"publish","type":"post","link":"https:\/\/neuronewsinternational.com\/endovascular-treatment-of-brain-aneurysms-is-under-5mm-a-go-or-no-go-area\/","title":{"rendered":"Endovascular treatment of brain aneurysms\u2014is under 5mm a \u2018go\u2019 or \u2018no-go\u2019 area?"},"content":{"rendered":"<figure id=\"attachment_13605\" aria-describedby=\"caption-attachment-13605\" style=\"width: 235px\" class=\"wp-caption alignleft\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-13605\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Victor-Volovici-thumbnail-2.jpg\" alt=\"\" width=\"235\" height=\"261\" \/><figcaption id=\"caption-attachment-13605\" class=\"wp-caption-text\">Victor Volovici<\/figcaption><\/figure>\n<p><strong>In light of <a href=\"https:\/\/jnis.bmj.com\/content\/16\/Suppl_1\/A279.1\" target=\"_blank\" rel=\"noopener\">recently presented and generally positive findings from the COAST study<\/a>, which deemed coiling to be safe in the treatment of small (<5mm) intracranial aneurysms, Victor Volovici (Rotterdam, The Netherlands) outlines existing clinical data, and weighs up the real-world pros and cons of this approach.<\/strong><\/p>\n<p>During a well-represented, high-stakes meeting on the treatment of intracranial aneurysms, a US physician once stated: \u201cCoiling aneurysms under 5mm is like voting for Trump\u2014nobody says they do it, and everybody does it\u201d.<\/p>\n<p>The question of whether aneurysms under 5mm should undergo treatment at all, and whether it is safe to do it, has been lingering in the minds of researchers and clinicians for at least the past two decades. The COAST study has made an important step towards a better understanding of the consequences of such a treatment. In order to better put these results in perspective, however, we should take into consideration the natural history of intracranial aneurysms, look at ruptured and unruptured aneurysms separately, and discuss blood blister-like aneurysms as well. One of the most often-heard arguments in favour of treatment when discussing small aneurysms is the discrepancy between natural history studies, showing a low longitudinal risk of haemorrhage from small aneurysms, on one hand, and retrospective analyses showing a preponderance of small aneurysms in large subarachnoid haemorrhage (SAH) series on the other.<\/p>\n<p>These facts make researchers conclude that, \u2018small aneurysms do bleed, and the risk of haemorrhage may be much higher than expected\u2019. On the one hand, natural history studies are, primarily, highly selected longitudinal registries of Japanese patients not selected for treatment. The aneurysms perceived morphologically to pose a higher risk were treated and were thus not eligible for follow-up. This state of affairs makes natural history data heavily confounded by indication and likely an underestimation of the true risk in a non-representative population. On the other hand, epidemiologically, smaller aneurysms are the larger group\u2014their prevalence is much higher. Therefore, their higher prevalence in SAH studies should not come as a surprise and may purely reflect the mathematical distribution of aneurysm size in general. The truth probably lies somewhere in the middle, with natural history studies likely underestimating the true risk of rupture, but not to the extent suggested by these retrospective studies.<\/p>\n<p>The COAST study included 300 patients from 15 centres in the USA over a timespan of about five years. In terms of the ruptured aneurysms included, these were \u2018ISAT-type aneurysms\u2019, in which coiling was proven beneficial\u2014and it is good to see that, even for the smallest aneurysms on this spectrum, \u2018simple\u2019 coiling is feasible and should remain the go-to treatment. In terms of the unruptured aneurysms, this is where the discussion makes a turn into a greyer area. The abstract and the presentation of COAST do not give sufficient detail about the types of patients and the characteristics of the aneurysms included. Such a treatment can only be considered safe when its safety profile outweighs the lifelong bleeding risk. As such, whether a disability and mortality rate of \u2018just\u2019 2.4% makes the treatment safe is debatable. The treatment is preventive; therefore, it can only be justified in aneurysms in which the lifelong bleeding risk is higher. Treatment is perhaps also justifiable for relatively young patients without comorbidities, and less so for older patients. One important aspect of this treatment, nevertheless, is patient preference. Often\u2014especially in the USA\u2014patients have a very strong treatment preference, substantiated by the wealth of online information found on reputable websites. Many patients may be more than willing to accept the 49-to-1 odds of a negative outcome.<\/p>\n<p>In addition, no mention is made in the abstract or the presentation about blood blister-like aneurysms. While certain people do not agree with this terminology, and there are debates over whether these aneurysms truly \u2018exist\u2019 as a separate pathological entity, some reports suggest a more fragile aneurysmal wall and thus a greater risk of periprocedural rupture. The optimal strategy regarding blood blister-like aneurysms remains incompletely assessed. All aspects considered, <a href=\"https:\/\/neuronewsinternational.com\/coast-is-clear-study-finds-coiling-safe-in-small-brain-aneurysms\/\" target=\"_blank\" rel=\"noopener\">the COAST is not clear yet<\/a>\u2014but most rooms have been confirmed to be enemy-free by the interventional team.<\/p>\n<p> <\/p>\n<p><strong><em>Victor Volovici<\/em><\/strong><em> is a cerebrovascular and skull-base neurosurgeon, methodologist, and clinical epidemiologist\u2014and co-director of the Center for Complex Microvascular Surgery\u2014at Erasmus University Medical Center in Rotterdam, The Netherlands.<\/em><\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>In light of recently presented and generally positive findings from the COAST study, which deemed coiling to be safe in the treatment of small (<5mm) intracranial aneurysms, Victor Volovici (Rotterdam, The Netherlands) outlines existing clinical data, and weighs up the real-world pros and cons of this approach. During a well-represented, high-stakes meeting on the treatment […]<\/p>\n","protected":false},"author":5277,"featured_media":13606,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[1144,2663,132,584,524,39,2477,2810],"class_list":["post-13604","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-features","tag-brain-aneurysms","tag-coast-study","tag-coil-embolisation","tag-coiling","tag-endovascular","tag-intracranial-aneurysm","tag-medical-management","tag-small-aneurysms"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Endovascular treatment of brain aneurysms\u2014is under 5mm a \u2018go\u2019 or \u2018no-go\u2019 area?<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/endovascular-treatment-of-brain-aneurysms-is-under-5mm-a-go-or-no-go-area\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Endovascular treatment of brain aneurysms\u2014is under 5mm a \u2018go\u2019 or \u2018no-go\u2019 area?\" \/>\n<meta property=\"og:description\" content=\"In light of recently presented and generally positive findings from the COAST study, which deemed coiling to be safe in the treatment of small (<5mm) intracranial aneurysms, Victor Volovici (Rotterdam, The Netherlands) outlines existing clinical data, and weighs up the real-world pros and cons of this approach. During a well-represented, high-stakes meeting on the treatment […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/endovascular-treatment-of-brain-aneurysms-is-under-5mm-a-go-or-no-go-area\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-13T11:55:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Victor-Volovici-featured-2.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"766\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jamie Bell\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@NN_publishing\" \/>\n<meta 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strengthens strategic partnership with Sim&Cure to expand innovation in neurovascular therapy"},"content":{"rendered":"<p><strong><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-13601 alignleft\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Philips-simnsize-thumbnail.jpg\" alt=\"\" width=\"240\" height=\"193\" \/>Royal Philips\u00a0has today announced the expansion of its strategic partnership with Sim&Cure\u2014a partnership that started five years ago and is now entering into its next phase with the aim of further enhancing Philips\u2019 position in the <a href=\"https:\/\/neuronewsinternational.com\/tag\/neurointervention\/\" target=\"_blank\" rel=\"noopener\">neurointerventional<\/a> domain by integrating Sim&Size software into Philips\u2019 next-generation image-guided therapy platform, Azurion.<\/strong><\/p>\n<p>This advanced connection offers care providers a more seamless, intuitive and efficient workflow for treating complex brain aneurysms, according to a Philips press release.<\/p>\n<p>In addition, the two companies will be developing new synergies through common projects to drive innovation into the future of cath labs.<\/p>\n<p>The release notes that current planning and device selection methods in brain aneurysm care involve multiple manual steps, increasing both procedure time and variability. But, by integrating Sim&Size into Azurion, physicians can now simulate device placement, optimise selection and guide deployment directly within the Azurion platform, eliminating the need for separate software and hardware setups, and enabling greater precision and efficiency in neurovascular procedures.<\/p>\n<p>\u201cThe strengthened collaboration with Sim&Cure allows us to bring the power of simulation and image-guided therapy together in one platform, enhancing physician confidence and improving patient outcomes,\u201d said Nicole Hermkens, vice president of marketing for Image-Guided Therapy (IGT) Systems at Philips. \u201cBy integrating Sim&Size into our Azurion platform, we are reducing complexity and variability in neurovascular procedures, ultimately helping to address the growing burden of brain aneurysms.\u201d<\/p>\n<p>\u201cWe are excited to deepen our relationship with Philips and expand our joint impact in neurovascular therapy,\u201d added Mathieu Sanchez, chief executive officer (CEO) of Sim&Cure. \u201cOur combined offering allows clinicians to confidently plan and execute minimally invasive treatments, bringing the best of both companies\u2019 innovations to bear for improved patient care.\u201d<\/p>\n<p>Philips claims that, since its launch in 2017, Azurion has been used to treat more than five million patients in over 90 countries. Earlier this year, the company\u00a0introduced\u00a0the latest version of Azurion\u2014a biplane model designed specifically to support neurointerventions that features enhanced 2D and 3D imaging capabilities, improved C-arm rotation flexibility, and optimised workflow features to help clinicians perform complex neurovascular procedures more effectively and efficiently.<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>Royal Philips\u00a0has today announced the expansion of its strategic partnership with Sim&Cure\u2014a partnership that started five years ago and is now entering into its next phase with the aim of further enhancing Philips\u2019 position in the neurointerventional domain by integrating Sim&Size software into Philips\u2019 next-generation image-guided therapy platform, Azurion. This advanced connection offers care providers […]<\/p>\n","protected":false},"author":5277,"featured_media":13602,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[1543,481,1144,169,2713,2809],"class_list":["post-13600","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-latest-news","tag-aneurysm-care","tag-azurion","tag-brain-aneurysms","tag-philips","tag-simcure","tag-simsize"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Philips strengthens strategic partnership with Sim&Cure to expand innovation in neurovascular therapy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/philips-strengthens-strategic-partnership-with-simcure-to-expand-innovation-in-neurovascular-therapy\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Philips strengthens strategic partnership with Sim&Cure to expand innovation in neurovascular therapy\" \/>\n<meta property=\"og:description\" content=\"Royal Philips\u00a0has today announced the expansion of its strategic partnership with Sim&Cure\u2014a partnership that started five years ago and is now entering into its next phase with the aim of further enhancing Philips\u2019 position in the neurointerventional domain by integrating Sim&Size software into Philips\u2019 next-generation image-guided therapy platform, Azurion. This advanced connection offers care providers […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/philips-strengthens-strategic-partnership-with-simcure-to-expand-innovation-in-neurovascular-therapy\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-12T15:30:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Philips-simnsize-featured.png\" \/>\n\t<meta property=\"og:image:width\" content=\"766\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Jamie Bell\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@NN_publishing\" 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Vascular presents early data on Algo smart pump at BRAIN conference"},"content":{"rendered":"<figure id=\"attachment_13597\" aria-describedby=\"caption-attachment-13597\" style=\"width: 450px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-13597\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Manning-Hanser-BRAIN-conference-thumbnail.jpg\" alt=\"\" width=\"450\" height=\"300\" srcset=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Manning-Hanser-BRAIN-conference-thumbnail.jpg 450w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Manning-Hanser-BRAIN-conference-thumbnail-300x200.jpg 300w\" sizes=\"auto, (max-width: 450px) 100vw, 450px\" \/><figcaption id=\"caption-attachment-13597\" class=\"wp-caption-text\">Manning Hanser presenting at the BRAIN conference<\/figcaption><\/figure>\n<p><strong>Von Vascular has announced the first international presentation of data on its Algo smart pump at the\u00a02024 BRAIN conference (2\u20134 December, London, UK). The preclinical studies\u2014presented by Von Vascular chief executive officer (CEO) Manning Hanser on behalf of principal investigators Brian Jankowitz (Hackensack Meridian Health, Edison, USA) and Robert Starke (University of Miami, Miami, USA)\u2014demonstrated the device’s potential to improve outcomes in mechanical thrombectomy procedures for acute ischaemic stroke patients.<\/strong><\/p>\n<p>Von Vascular\u2019s Algo smart pump introduces a dual-modality approach to <a href=\"https:\/\/neuronewsinternational.com\/tag\/cyclic-aspiration\/\" target=\"_blank\" rel=\"noopener\">cyclical aspiration technology for mechanical thrombectomy<\/a>. The pump offers two distinct aspiration modes: adaptive pulsatile aspiration (APA) and an enhanced static mode. A recent press release from the company notes that this design acknowledges the fact that different clots may respond better to specific types of aspiration, providing clinicians with tailored options to optimise treatment. The goal is to achieve complete clot ingestion (CCI) into the aspiration catheter while minimising the risk of generating micro-emboli, the release adds.<\/p>\n<p>“It was great to share these promising results at the BRAIN conference,” said Hanser. “Algo has the potential to address the critical gap between high recanalisation rates and suboptimal functional outcomes in stroke patients. By reducing micro-emboli formation and improving clot ingestion efficiency, we aim to enhance long-term neurological recovery and overall patient care.”<\/p>\n<p>Early preclinical studies have highlighted the Algo smart pump’s \u201csignificant advantages\u201d over conventional aspiration systems in achieving CCI and reducing emboli formation, the release further claims. Both the APA and static modes of the pump demonstrated improved CCI rates, with the APA mode showing the most pronounced impact. In comparative testing, 77.2% of clots were successfully ingested using Algo\u2019s APA mode, compared to just 36.7% with conventional aspiration systems (p<0.001). Additionally, the Algo smart pump reduced aspiration time\u2014a factor previously linked to improved patient outcomes.<\/p>\n<p>The release states that this innovative, dual-mode approach and investment in preclinical studies reflect Von Vascular\u2019s dedication to advancing stroke thrombectomy technology, and enhancing care for patients globally.<\/p>\n<p>“The novel approach presented by Von Vascular is a significant advancement in mechanical thrombectomy technology,\u201d said BRAIN conference director Paul Bhogal (Royal London Hospital, London, UK), commenting on the presentation. \u201cReducing micro-emboli formation is crucial for improving patient outcomes.”<\/p>\n<p>Von Vascular\u2019s recent release concludes by noting that the Algo smart pump’s potential to positively impact 90-day modified Rankin scale (mRS) scores by addressing microvascular occlusions represents a \u201cnoteworthy development\u201d in stroke intervention\u2014and the company hopes to further validate these findings in a clinical setting, and bring this technology to physicians and patients worldwide.<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>Von Vascular has announced the first international presentation of data on its Algo smart pump at the\u00a02024 BRAIN conference (2\u20134 December, London, UK). The preclinical studies\u2014presented by Von Vascular chief executive officer (CEO) Manning Hanser on behalf of principal investigators Brian Jankowitz (Hackensack Meridian Health, Edison, USA) and Robert Starke (University of Miami, Miami, USA)\u2014demonstrated […]<\/p>\n","protected":false},"author":5277,"featured_media":13598,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[2674,934,2808,2564,2672],"class_list":["post-13596","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-latest-news","tag-algo-smart-pump","tag-aspiration-thrombectomy","tag-brain-2024","tag-cyclic-aspiration","tag-von-vascular"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Von Vascular presents early data on Algo smart pump at BRAIN conference<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/von-vascular-presents-early-data-on-algo-smart-pump-at-brain-conference\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Von Vascular presents early data on Algo smart pump at BRAIN conference\" \/>\n<meta property=\"og:description\" content=\"Von Vascular has announced the first international presentation of data on its Algo smart pump at the\u00a02024 BRAIN conference (2\u20134 December, London, UK). The preclinical studies\u2014presented by Von Vascular chief executive officer (CEO) Manning Hanser on behalf of principal investigators Brian Jankowitz (Hackensack Meridian Health, Edison, USA) and Robert Starke (University of Miami, Miami, USA)\u2014demonstrated […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/von-vascular-presents-early-data-on-algo-smart-pump-at-brain-conference\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-12T10:46:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Manning-Hanser-BRAIN-conference-featured.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"766\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" 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The preclinical studies\u2014presented by Von Vascular chief executive officer (CEO) Manning Hanser on behalf of principal investigators Brian Jankowitz (Hackensack Meridian Health, Edison, USA) and Robert Starke (University of Miami, Miami, USA)\u2014demonstrated […]","og_url":"https:\/\/neuronewsinternational.com\/von-vascular-presents-early-data-on-algo-smart-pump-at-brain-conference\/","og_site_name":"NeuroNews International","article_publisher":"https:\/\/www.facebook.com\/NeuroNews","article_published_time":"2024-12-12T10:46:33+00:00","og_image":[{"width":766,"height":512,"url":"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Manning-Hanser-BRAIN-conference-featured.jpg","type":"image\/jpeg"}],"author":"Jamie Bell","twitter_card":"summary_large_image","twitter_creator":"@NN_publishing","twitter_site":"@NN_publishing","twitter_misc":{"Written by":"Jamie Bell","Estimated reading time":"3 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receives US FDA approval for IDE study of innovative cyclic aspiration system"},"content":{"rendered":"<p><strong><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-12536 alignleft\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/04\/RapidPulse-logo-thumbnail-1.jpg\" alt=\"\" width=\"222\" height=\"233\" \/>RapidPulse announced today that the US Food and Drug Administration (FDA) has agreed that the company can begin enrolment in an investigational device exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow US and European patient enrolment in 2025 as part of a study designed to demonstrate that RapidPulse\u2019s patented method of precisely pulsed aspiration is safe and effective in the treatment of <a href=\"https:\/\/neuronewsinternational.com\/tag\/acute-ischaemic-stroke\/\" target=\"_blank\" rel=\"noopener\">acute ischaemic stroke<\/a>. A press release notes that the company\u2019s technology is a spinout of Syntheon 2.0\u2014an innovative medical device incubator with a long track record of successful exits.<\/strong><\/p>\n<p>The RapidPulse system that will be used in the IDE study was recently trialled in 19 large vessel occlusion (LVO) patients enrolled at Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asuncion in San Lorenzo, Paraguay and Istanbul Aydin Universitesi in Istanbul, T\u00fcrkiye.<\/p>\n<p>\u201cUsing the new RapidPulse system, we achieved a 68% first-pass effect of TICI [thrombolysis in cerebral infarction] 2c or better. This means almost seven out of 10 acute ischaemic stroke patients had near perfect or perfect reperfusion after one attempt. We were just as impressed that the RapidPulse catheter is as navigable as the benchmark catheters on the market, and that 100% of patients achieved TICI 2b or higher within three passes,\u201d said leading investigator Serdar Geyik (Istanbul Aydin Universitesi, Istanbul, T\u00fcrkiye).<\/p>\n<p>The RapidPulse pivotal study is targeted to enrol approximately 170 patients with recent onset of symptoms indicative of LVO in acute ischaemic stroke. Upon completion of the study, data will be submitted to the US FDA for consideration of RapidPulse receiving 510(k) clearance to market the device.<\/p>\n<p>The company\u2019s release details that, while previously FDA-cleared devices for the treatment of stroke have used either static aspiration, a stent retriever, or a combination of the two, many published studies have shown these currently available technologies only achieve complete or near complete reperfusion on the first attempt in approximately four out of 10 patients. RapidPulse claims to be the first company to patent a system that rapidly cycles aspiration, and is designed to improve the rate of full clot ingestion with higher reperfusion rates on the first pass and demonstrate impressive results when up to three passes are made.<\/p>\n<p>RapidPulse has developed a complete system, including a proprietary console to deliver precise, pulsed aspiration, as well as highly trackable catheters, and a smart tubing set that ensures the company\u2019s proprietary cyclic algorithm is tuned to each catheter size.<\/p>\n<p>\u201cThrough our extensive development work, we know the algorithm\u2019s precision and how it is translated through the catheter to the clot face is critical to high success rates,\u201d said Sean McBrayer, chief executive officer (CEO) of RapidPulse. \u201cOur system is made to allow stroke teams to quickly and easily get a really powerful tool for clot removal to the right location, so they have the best chance of restoring full reperfusion on the first pass.\u201d<\/p>\n<p><a href=\"https:\/\/journals.sagepub.com\/doi\/10.1177\/15910199241239094\" target=\"_blank\" rel=\"noopener\">A prior study with the RapidPulse system<\/a> demonstrated physicians were able to achieve a 21-point improvement in their first-pass clot removal rate when compared to contemporary patients who were treated with static aspiration alone, the company also claims in today\u2019s release.<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>RapidPulse announced today that the US Food and Drug Administration (FDA) has agreed that the company can begin enrolment in an investigational device exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow US and European patient enrolment in 2025 as part of a study designed to demonstrate that RapidPulse\u2019s patented […]<\/p>\n","protected":false},"author":5277,"featured_media":12534,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[934,2564,820,688,2563],"class_list":["post-13594","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-latest-news","tag-aspiration-thrombectomy","tag-cyclic-aspiration","tag-first-pass-effect","tag-ide-trial","tag-rapidpulse"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>RapidPulse receives US FDA approval for IDE study of innovative cyclic aspiration system<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/rapidpulse-receives-us-fda-approval-for-ide-study-of-innovative-cyclic-aspiration-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RapidPulse receives US FDA approval for IDE study of innovative cyclic aspiration system\" \/>\n<meta property=\"og:description\" content=\"RapidPulse announced today that the US Food and Drug Administration (FDA) has agreed that the company can begin enrolment in an investigational device exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow US and European patient enrolment in 2025 as part of a study designed to demonstrate that RapidPulse\u2019s patented […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/rapidpulse-receives-us-fda-approval-for-ide-study-of-innovative-cyclic-aspiration-system\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-11T16:42:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/04\/RapidPulse-logo-featured.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"766\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jamie Bell\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@NN_publishing\" \/>\n<meta name=\"twitter:site\" content=\"@NN_publishing\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jamie Bell\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/neuronewsinternational.com\/rapidpulse-receives-us-fda-approval-for-ide-study-of-innovative-cyclic-aspiration-system\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/neuronewsinternational.com\/rapidpulse-receives-us-fda-approval-for-ide-study-of-innovative-cyclic-aspiration-system\/\"},\"author\":{\"name\":\"Jamie 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sex, disease severity and vasospasm among predictors of post-SAH delayed cerebral infarction risk"},"content":{"rendered":"<p><strong><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-12651 alignleft\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/05\/Human-brain-model-thumbnail.jpg\" alt=\"\" width=\"240\" height=\"192\" \/>A meta-analysis of more than 4,500 patients, presented recently at the 16th\u00a0World Stroke Congress (WSC; 23\u201326 October, Abu Dhabi, United Arab Emirates), has revealed that female sex; disease severity upon admission; presence of vasospasm; and scores on the Fisher grading scale, are all useful predictors of delayed cerebral infarction (DCI) risk following an aneurysmal <a href=\"https:\/\/neuronewsinternational.com\/tag\/sah\/\" target=\"_blank\" rel=\"noopener\">subarachnoid haemorrhage (SAH)<\/a>.<\/strong><\/p>\n<p>However, delivering these findings at WSC 2024, Syed Gillani (University of Missouri, Columbia, USA) noted that \u201csignificant knowledge gaps exist\u201d regarding predictors of early cerebral infarction (ECI) risk. Gillani went on to state that further large, standardised cohort studies are warranted to guide prognosis and interventions on this front.<\/p>\n<p>With predictors of both DCI and ECI among aneurysmal SAH patients remaining \u201cunclear\u201d prior to their analysis, Gillani and colleagues set out to systematically review and synthesise existing literature on these phenomena.<\/p>\n<p>They conducted a comprehensive search of PubMed, Embase, Cochrane Library and Scopus databases from inception to January 2024, with the goal of documenting any observational cohort studies examining predictors of DCI or ECI following aneurysmal SAH through this period. Studies were screened, reviewed, and meta-analysed, adhering to Preferred reporting items for systematic reviews and meta-analyses (PRISMA) and Cochrane guidelines. The data were then pooled as odds ratios (OR) with 95% confidence intervals (CI) using RevMan 5.4 software. Methodologic quality was assessed via the Newcastle-Ottawa scale.<\/p>\n<p>\u201cOur meta-analysis included 12 moderate- to high-quality cohort studies, comprising 4,527 patients,\u201d Gillani and colleagues state.<\/p>\n<p>Regarding DCI predictors, they ultimately found that higher disease severity scores (OR, 1.49; 95% CI, 1.12\u20131.97; p=0.005) and high Fisher grading scale scores (OR, 2.23; 95% CI, 1.28\u20133.89; p=0.005) on presentation were \u201csignificantly associated\u201d with an increased risk of DCI. They also observed female sex and the presence of vasospasm as having been significantly associated with an increased risk of DCI (OR, 3.04; 95% CI, 1.35\u20136.88; p=0.007).<\/p>\n<p>In contrast, the investigators found that pre-existing hypertension (p=0.94), aneurysm treatment (p=0.14) and aneurysm location (p=0.16) were among factors that \u201cdid not reliably predict DCI risk\u201d.<\/p>\n<p>Regarding ECI predictors, Gillani and colleagues\u2019 pooled analysis demonstrated \u201cno significant associations\u201d between sex (p=0.51), pre-existing hypertension (p=0.63), disease severity (p=0.51), or anterior versus posterior aneurysm location (p=0.86), and the occurrence of ECI in aneurysmal SAH patients.<\/p>\n<p>In addition to being presented by Gillani at WSC 2024, the results of this systematic review and meta-analysis have now been published in the journal <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S1878875024010180?via%3Dihub\"><em>World Neurosurgery<\/em><\/a>.<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>A meta-analysis of more than 4,500 patients, presented recently at the 16th\u00a0World Stroke Congress (WSC; 23\u201326 October, Abu Dhabi, United Arab Emirates), has revealed that female sex; disease severity upon admission; presence of vasospasm; and scores on the Fisher grading scale, are all useful predictors of delayed cerebral infarction (DCI) risk following an aneurysmal subarachnoid […]<\/p>\n","protected":false},"author":5277,"featured_media":12652,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[1768,2468,972,2352,1836,2729],"class_list":["post-13591","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-latest-news","tag-asah","tag-cerebral-infarction","tag-cerebral-vasospasm","tag-sah","tag-world-neurosurgery","tag-wsc-2024"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Female sex, disease severity and vasospasm among predictors of post-SAH delayed cerebral infarction risk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/female-sex-disease-severity-vasospasm-post-sah-dci-risk\/\" \/>\n<meta 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Pharma closes \u20ac5 million seed extension financing to accelerate breakthrough ICH therapy"},"content":{"rendered":"<p><strong><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-13587 size-full\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Alveron-Pharma-logo-thumbnail.jpg\" alt=\"\" width=\"235\" height=\"204\" \/>Alveron Pharma\u00a0has announced the closing of a \u20ac5 million series seed extension financing\u2014worth approximately US$5.28 million\u2014to advance the development of its innovative drug, OKL-1111, for the treatment of <a href=\"https:\/\/neuronewsinternational.com\/tag\/ich\/\" target=\"_blank\" rel=\"noopener\">intracranial haemorrhage (ICH)<\/a>. The syndicate behind this funding is led by Broadview Ventures, and features participation from all existing investors, including Sanquin (the Dutch Blood Foundation), Thuja Capital, Waterman Ventures and Oost NL.<\/strong><\/p>\n<p>\u201cWith the support from our syndicate of specialist life science investors, alongside the expertise of our scientific advisory board, we are eager to advance our innovative therapeutic approach and improve patient outcomes,\u201d said Alveron chief executive officer (CEO) Ben Nichols.<\/p>\n<p>Alveron is developing a synthetic anticoagulant and platelet inhibitor reversal agent to prevent haematoma expansion and improve clinical outcomes in patients with ICH.<\/p>\n<p>A press release from the company notes that current therapies for treating ICH patients on anticoagulants have \u201ccumbersome regimens\u201d, resulting in excessive door-to-needle times\u2014often exceeding two hours\u2014which exacerbate poor outcomes for these patients.<\/p>\n<p>OKL-1111 has a universal mode of action by binding to a downstream clotting factor and a unique product profile, enabling administration within 10 minutes of a diagnosing computed tomography (CT) scan, Alveron claims. In addition, the drug reverses the effects of clopidogrel\u2014a major platelet inhibitor, for which there is currently no antidote.<\/p>\n<p>The capital provided from this new financing will enable Alveron to \u201caccelerate important development activities\u201d that support OKL-1111\u2019s readiness for further clinical studies to demonstrate safety and proof-of-concept efficacy in patients, according to the company.<\/p>\n<p>Benjamin Kreitman, principal at Broadview Ventures, commented: “Intracranial haemorrhage remains a severe unmet medical need, and the development of novel treatments to reverse both anticoagulants and platelet inhibitors could deliver a meaningful improvement in the long-term outcomes of ICH patients. As Broadview’s investment strategy is focused on the improvement of human health in the areas of cardiovascular disease and stroke, we are delighted to accelerate this highly innovative approach in this indication of significant unmet need.”<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>Alveron Pharma\u00a0has announced the closing of a \u20ac5 million series seed extension financing\u2014worth approximately US$5.28 million\u2014to advance the development of its innovative drug, OKL-1111, for the treatment of intracranial haemorrhage (ICH). The syndicate behind this funding is led by Broadview Ventures, and features participation from all existing investors, including Sanquin (the Dutch Blood Foundation), Thuja […]<\/p>\n","protected":false},"author":5277,"featured_media":13588,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[2806,1613,173,2807,1545],"class_list":["post-13586","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-latest-news","tag-alveron-pharma","tag-ich","tag-intracranial-haemorrhage","tag-okl-1111","tag-seed-funding"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Alveron Pharma closes \u20ac5 million seed extension financing to accelerate breakthrough ICH therapy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/alveron-pharma-closes-e5-million-seed-extension-financing-to-accelerate-breakthrough-ich-therapy\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alveron Pharma closes \u20ac5 million seed extension financing to accelerate breakthrough ICH therapy\" \/>\n<meta property=\"og:description\" content=\"Alveron Pharma\u00a0has announced the closing of a \u20ac5 million series seed extension financing\u2014worth approximately US$5.28 million\u2014to advance the development of its innovative drug, OKL-1111, for the treatment of intracranial haemorrhage (ICH). The syndicate behind this funding is led by Broadview Ventures, and features participation from all existing investors, including Sanquin (the Dutch Blood Foundation), Thuja […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/alveron-pharma-closes-e5-million-seed-extension-financing-to-accelerate-breakthrough-ich-therapy\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-10T16:54:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Alveron-Pharma-logo-featured.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"766\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jamie Bell\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@NN_publishing\" \/>\n<meta name=\"twitter:site\" content=\"@NN_publishing\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jamie Bell\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/neuronewsinternational.com\/alveron-pharma-closes-e5-million-seed-extension-financing-to-accelerate-breakthrough-ich-therapy\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/neuronewsinternational.com\/alveron-pharma-closes-e5-million-seed-extension-financing-to-accelerate-breakthrough-ich-therapy\/\"},\"author\":{\"name\":\"Jamie 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The syndicate behind this funding is led by Broadview Ventures, and features participation from all existing investors, including Sanquin (the Dutch Blood Foundation), Thuja […]","og_url":"https:\/\/neuronewsinternational.com\/alveron-pharma-closes-e5-million-seed-extension-financing-to-accelerate-breakthrough-ich-therapy\/","og_site_name":"NeuroNews International","article_publisher":"https:\/\/www.facebook.com\/NeuroNews","article_published_time":"2024-12-10T16:54:06+00:00","og_image":[{"width":766,"height":512,"url":"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Alveron-Pharma-logo-featured.jpg","type":"image\/jpeg"}],"author":"Jamie Bell","twitter_card":"summary_large_image","twitter_creator":"@NN_publishing","twitter_site":"@NN_publishing","twitter_misc":{"Written by":"Jamie Bell","Estimated reading time":"2 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patient enrolled in InspireMD\u2019s CGUARDIANS II pivotal study"},"content":{"rendered":"<figure id=\"attachment_17164\" aria-describedby=\"caption-attachment-17164\" style=\"width: 250px\" class=\"wp-caption alignleft\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-13583\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Patrick-Muck.jpg\" alt=\"\" width=\"250\" height=\"210\" \/><figcaption id=\"caption-attachment-17164\" class=\"wp-caption-text\">Patrick Muck<\/figcaption><\/figure>\n<p align=\"left\"><strong><a href=\"https:\/\/vascularnews.com\/tag\/inspiremd\/\">InspireMD<\/a>\u00a0today announced that the first patient has been enrolled in the company\u2019s CGUARDIANS II clinical trial evaluating its CGuard Prime carotid stent system in patients undergoing <a href=\"https:\/\/vascularnews.com\/tag\/carotid-artery-stenting\/\">carotid artery stenting (CAS)<\/a> via the <a href=\"https:\/\/vascularnews.com\/tag\/tcar\/\">transcarotid artery revascularisation (TCAR)<\/a> approach. The patient was enrolled by Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, USA. Muck serves as both the site principal investigator as well as a co-lead investigator of the CGUARDIANS II study.<\/strong><\/p>\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT06653387?term=CGUARDIANS%20II&rank=1\">CGUARDIANS II<\/a> is a prospective, multicentre, single-arm pivotal study that aims to enrol a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with a US Food and Drug Administration (FDA)-cleared TCAR neuroprotection system in patients at high risk for adverse events from <a href=\"https:\/\/vascularnews.com\/tag\/carotid-endarterectomy\/\">carotid endarterectomy<\/a>.<\/p>\n<p>Marvin Slosman, chief executive officer of InspireMD, commented: \u201cAs we approach potential FDA approval of CGuard Prime with a CAS indication in the first half of next year, we are thrilled to have initiated the CGUARDIANS II study that, if successful, will address an ever-expanding TCAR market of roughly 30,000 procedures performed in the USA this year. I would like to thank Dr Muck for helping us achieve this initial and critical enrolment milestone, and I look forward to the efficient execution of this important study as we work to enable the use of CGuard Prime in the broadest application, offering patients and physicians this next-generation stenting platform, which has demonstrated best-in-class clinical outcomes in rigorous clinical studies and with over 60,000 devices sold to date.\u201d<\/p>\n<p>Muck, who is programme director and chief of vascular surgery at Good Samaritan Hospital, stated: \u201cAs we begin this study of CGuard Prime in a TCAR setting, we value tremendously the prior data from the C-GUARDIANS PMA [premarket approval], the real-world results of this implant and its potential to advance patient care through these unmatched clinical results. The protective qualities of the MicroNet mesh offer patients the sustainable protection which is so important in both short- and long-term outcomes of this procedure. We look forward to the efficient enrolment of this study, contribution from the team of investigators and working with InspireMD on this important programme.\u201d<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>InspireMD\u00a0today announced that the first patient has been enrolled in the company\u2019s CGUARDIANS II clinical trial evaluating its CGuard Prime carotid stent system in patients undergoing carotid artery stenting (CAS) via the transcarotid artery revascularisation (TCAR) approach. The patient was enrolled by Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, […]<\/p>\n","protected":false},"author":2254,"featured_media":13583,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[1483,1174,650],"class_list":["post-13582","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-latest-news","tag-carotid","tag-carotid-artery-stenting","tag-inspiremd"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>First patient enrolled in InspireMD\u2019s CGUARDIANS II pivotal study - NeuroNews International<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First patient enrolled in InspireMD\u2019s CGUARDIANS II pivotal study - NeuroNews International\" \/>\n<meta property=\"og:description\" content=\"InspireMD\u00a0today announced that the first patient has been enrolled in the company\u2019s CGUARDIANS II clinical trial evaluating its CGuard Prime carotid stent system in patients undergoing carotid artery stenting (CAS) via the transcarotid artery revascularisation (TCAR) approach. The patient was enrolled by Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-09T16:13:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-12-09T16:27:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Patrick-Muck.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"250\" \/>\n\t<meta property=\"og:image:height\" content=\"210\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jocelyn Hudson\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@NN_publishing\" \/>\n<meta name=\"twitter:site\" content=\"@NN_publishing\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jocelyn Hudson\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/\"},\"author\":{\"name\":\"Jocelyn Hudson\",\"@id\":\"https:\/\/neuronewsinternational.com\/#\/schema\/person\/f1566fe55b2ab1b136d625ed20696392\"},\"headline\":\"First patient enrolled in InspireMD\u2019s CGUARDIANS II pivotal study\",\"datePublished\":\"2024-12-09T16:13:09+00:00\",\"dateModified\":\"2024-12-09T16:27:38+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/\"},\"wordCount\":389,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/neuronewsinternational.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Patrick-Muck.jpg\",\"keywords\":[\"carotid\",\"carotid artery stenting\",\"InspireMD\"],\"articleSection\":[\"Latest News\"],\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/\",\"url\":\"https:\/\/neuronewsinternational.com\/first-patient-enrolled-in-inspiremds-cguardians-ii-pivotal-study\/\",\"name\":\"First patient enrolled in InspireMD\u2019s CGUARDIANS II pivotal study - 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top 10 most popular stories of November 2024"},"content":{"rendered":"<p><strong><em><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-8768 aligncenter\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1.jpg\" alt=\"\" width=\"2048\" height=\"1369\" srcset=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1.jpg 2048w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1-300x201.jpg 300w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1-1024x685.jpg 1024w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1-1536x1027.jpg 1536w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1-628x420.jpg 628w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1-537x360.jpg 537w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1-640x428.jpg 640w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1-681x455.jpg 681w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1-500x334.jpg 500w\" sizes=\"auto, (max-width: 2048px) 100vw, 2048px\" \/>NeuroNews\u2019<\/em> November top 10 features a number of stories reporting new data and discussions around stroke thrombectomy\u2014not only relating to its clinical effects, but also its real-world applicability. The perennial hot topic of endovascular treatment in chronic subdural haematoma (cSDH) is also present, owing to the long-anticipated publication of three landmark studies evaluating middle meningeal artery (MMA) embolisation and the recent release of findings from a fourth randomised trial in this space.<\/strong><\/p>\n<h4>1. <a href=\"https:\/\/neuronewsinternational.com\/route-92-gains-eu-and-mdsap-certification-for-its-neurovascular-product-portfolio\/\">Route 92 gains EU and MDSAP certification for its neurovascular product portfolio<\/a><\/h4>\n<p>Route 92 Medical has announced that it has obtained CE-mark approval under the EU Medical Device Regulation (MDR) 2017\/745 for its innovative line of\u00a0<a href=\"https:\/\/neuronewsinternational.com\/tag\/neurovascular\/\">neurovascular<\/a>, stroke intervention-focused products. Concurrently, the company also announced clearance under the Medical Device Single Audit Program\u00a0(MDSAP), which gives broad access to international markets.<\/p>\n<h4>2. <a href=\"https:\/\/neuronewsinternational.com\/every-hour-saved-between-stroke-onset-and-thrombectomy-could-equate-to-25-greater-odds-of-functional-independence\/\">Every hour saved between stroke onset and thrombectomy could equate to 25% greater odds of functional independence<\/a><\/h4>\n<p>A systematic review and meta-analysis of five studies and more than 11,000 patient records has indicated that each hour saved between acute ischaemic stroke symptom onset and initiating a\u00a0<a href=\"https:\/\/neuronewsinternational.com\/tag\/mechanical-thrombectomy\/\">mechanical thrombectomy<\/a>\u00a0procedure is associated with a 22\u201325% increase in the odds of achieving functional independence.<\/p>\n<h4>3. <a href=\"https:\/\/neuronewsinternational.com\/landmark-mma-embolisation-trials-published-in-new-england-journal-of-medicine\/\">Landmark MMA embolisation trials published in <em>New England Journal of Medicine<\/em><\/a><\/h4>\n<p>Detailed results from three randomised controlled trials (RCTs) evaluating middle meningeal artery (MMA) embolisation in the treatment of chronic subdural haematoma (cSDH) have been published in the\u00a0<em>New England Journal of Medicine (NEJM)<\/em>. With key initial data from each having been presented at the 2024 International Stroke Conference (ISC; 7\u20139 February, Phoenix, USA), EMBOLISE, STEM and MAGIC-MT were made available in\u00a0<em>NEJM<\/em>\u00a0on 20 November.<\/p>\n<h4>4. <a href=\"https:\/\/neuronewsinternational.com\/endostream-announces-european-mdr-certification-of-nautilus-intrasaccular-system\/\">Endostream announces European MDR certification of Nautilus intrasaccular system<\/a><\/h4>\n<p>Endostream Medical has announced that it has officially received European Union (EU) Medical Device Regulation (MDR) certification for its Nautilus intrasaccular system\u2014a novel device intended for the treatment of\u00a0<a href=\"https:\/\/neuronewsinternational.com\/tag\/brain-aneurysms\/\">brain aneurysms<\/a>.<\/p>\n<h4>5. <a href=\"https:\/\/neuronewsinternational.com\/stroke-thrombectomy-large-core-limitless-potential-final-chapter\/\">Stroke thrombectomy: Limitless potential or a success story nearing its final chapter?<\/a><\/h4>\n<p>Mechanical thrombectomy\u00a0has gone from strength to strength in the treatment of acute ischaemic stroke over the past decade\u2014progressing beyond early-window large vessel occlusions (LVOs) to patients presenting >6 hours post-symptom onset and those with occlusions located in the posterior circulation. The latest frontier thrombectomy appears to have conquered is those cases characterised by more extensive infarcts on imaging, generally referred to as \u2018large-core\u2019 strokes. However, as alluded to by both Wim van Zwam (Maastricht, The Netherlands) and Joseph Broderick (Cincinnati, USA) in recent interviews with\u00a0<em>NeuroNews<\/em>, a number of important questions remain.<\/p>\n<h4>6. <a href=\"https:\/\/neuronewsinternational.com\/first-prospective-indian-thrombectomy-registry-shows-high-revascularisation-rates-and-confirms-procedure-is-cost-effective\/\">First prospective Indian thrombectomy registry shows high revascularisation rates and confirms procedure is cost effective<\/a><\/h4>\n<p>Data from a registry claimed to be the first prospective registry on\u00a0mechanical thrombectomy for stroke\u00a0in India have revealed a number of key insights on how this treatment is being implemented across the country. High revascularisation rates and good functional outcomes, as well as workflow metrics that are \u201ccomparable\u201d with those seen in other geographies, are among researchers\u2019 most notable findings.<\/p>\n<h4>7. <a href=\"https:\/\/neuronewsinternational.com\/membrane-becomes-latest-rct-to-demonstrate-mma-embolisations-benefits-in-csdh-treatment\/\">MEMBRANE becomes latest RCT to demonstrate MMA embolisation\u2019s benefits in cSDH treatment<\/a><\/h4>\n<p>The MEMBRANE randomised controlled trial (RCT)\u2014presented at the 2024 Society of Vascular and Interventional Neurology (SVIN) annual meeting (20\u201322 November, San Diego, USA) by Ansaar Rai (West Virginia University Rockefeller Neuroscience Institute, Morgantown, USA)\u2014has produced fresh evidence on the benefits offered by\u00a0<a href=\"https:\/\/neuronewsinternational.com\/tag\/mma-embolisation\/\">middle meningeal artery (MMA) embolisation<\/a>\u00a0as an adjunct to the current standard of care in chronic subdural haematoma (cSDH) patients.<\/p>\n<h4>8. <a href=\"https:\/\/neuronewsinternational.com\/thanh-n-nguyen-profile\/\">PROFILE: Thanh N Nguyen<\/a><\/h4>\n<p>As one of six women currently leading major neurointerventional societies across the globe, Thanh N Nguyen (Boston, USA) is proudly playing a key role in challenging the medical field\u2019s history of underrepresentation. In addition to her present tenure as president of the\u00a0<a href=\"https:\/\/neuronewsinternational.com\/tag\/svin\/\">Society of Vascular and Interventional Neurology (SVIN)<\/a>, Nguyen is also professor of neurology, neurosurgery and radiology at Boston University Chobanian and Avedisian School of Medicine, as well as director of Interventional Neuroradiology and Interventional Neurology, and attending physician in the Vascular Neurology Service, at Boston Medical Center. Here, Nguyen speaks to\u00a0<em>NeuroNews<\/em>\u00a0about her\u00a0<a href=\"https:\/\/neuronewsinternational.com\/tag\/neurointerventionists\/\">neurointerventional mentors<\/a>, ongoing efforts to boost gender equity in the field, and the most impactful clinical studies she has contributed to, among other topics.<\/p>\n<h4>9. <a href=\"https:\/\/neuronewsinternational.com\/taste-2-results-suggest-significant-reduction-in-stroke-related-disability-with-sanbexin\/\">TASTE-2 results suggest \u2018significant reduction\u2019 in stroke-related disability with Sanbexin<\/a><\/h4>\n<p>Simcere Pharmaceutical Group has announced that a new study with major clinical findings regarding Sanbexin\u2014an edaravone-dexborneol concentrated solution for injection\u2014was recently presented at the 16<sup>th<\/sup>\u00a0World Stroke Congress (WSC; 23\u201326 October, Abu Dhabi, United Arab Emirates). According to the data, the administration of Sanbexin prior to undergoing an\u00a0<a href=\"https:\/\/neuronewsinternational.com\/tag\/endovascular-therapy\/\">endovascular thrombectomy<\/a>\u00a0procedure significantly improved neurofunctional recovery and reduced stroke-related disability in patients with acute ischaemic stroke.<\/p>\n<h4>10. <a href=\"https:\/\/neuronewsinternational.com\/zeta-surgical-ai-powered-navigation-system-us-fda-clearance-expansion\/\">Zeta Surgical\u2019s AI-powered navigation system gains US FDA 510(k) clearance expansion<\/a><\/h4>\n<p>Zeta Surgical has announced that its\u00a0<a href=\"https:\/\/neuronewsinternational.com\/tag\/ai\/\">artificial intelligence (AI)-powered<\/a>\u00a0Zeta navigation system has received 510(k) clearance from the US Food and Drug Administration (FDA) for use with expanded instruments and enhanced hospital connectivity.<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>NeuroNews\u2019 November top 10 features a number of stories reporting new data and discussions around stroke thrombectomy\u2014not only relating to its clinical effects, but also its real-world applicability. The perennial hot topic of endovascular treatment in chronic subdural haematoma (cSDH) is also present, owing to the long-anticipated publication of three landmark studies evaluating middle meningeal […]<\/p>\n","protected":false},"author":5277,"featured_media":8768,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[1068],"class_list":["post-13580","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-features","tag-top10"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>NeuroNews\u2019 top 10 most popular stories of November 2024<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/neuronews-top-10-most-popular-stories-of-november-2024\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NeuroNews\u2019 top 10 most popular stories of November 2024\" \/>\n<meta property=\"og:description\" content=\"NeuroNews\u2019 November top 10 features a number of stories reporting new data and discussions around stroke thrombectomy\u2014not only relating to its clinical effects, but also its real-world applicability. The perennial hot topic of endovascular treatment in chronic subdural haematoma (cSDH) is also present, owing to the long-anticipated publication of three landmark studies evaluating middle meningeal […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/neuronews-top-10-most-popular-stories-of-november-2024\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-06T14:56:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2022\/04\/Top-10-web-graphic-2022_v1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2048\" \/>\n\t<meta property=\"og:image:height\" content=\"1369\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jamie Bell\" \/>\n<meta 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EVD catheter scoops US$100,000 SVINnovation prize"},"content":{"rendered":"<figure id=\"attachment_13577\" aria-describedby=\"caption-attachment-13577\" style=\"width: 550px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-13577\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/svinnovation-prize-money-pic-thumbnail.jpg\" alt=\"\" width=\"550\" height=\"367\" srcset=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/svinnovation-prize-money-pic-thumbnail.jpg 550w, https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/svinnovation-prize-money-pic-thumbnail-300x200.jpg 300w\" sizes=\"auto, (max-width: 550px) 100vw, 550px\" \/><figcaption id=\"caption-attachment-13577\" class=\"wp-caption-text\">Matt Findlay (far left) receiving the SVINnovation prize<\/figcaption><\/figure>\n<p><strong>A novel catheter intended to improve on the tools currently available in <a href=\"https:\/\/neuronewsinternational.com\/tag\/neurosurgery\/\" target=\"_blank\" rel=\"noopener\">neurosurgical<\/a> external ventricular drain (EVD) placement was awarded a US$100,000 grand prize at this year\u2019s Society of Vascular and Interventional Neurology (SVIN) annual meeting (20\u201322 November, San Diego, USA).<\/strong><\/p>\n<p>The SoundPass device\u2014conceived and developed by a team of medical students from the University of Utah (Salt Lake City, USA)\u2014was ultimately selected by an entrepreneurial panel of judges to receive this award ahead of three other technologies also showcased during <a href=\"https:\/\/www.svin.org\/i4a\/pages\/index.cfm?pageID=3696\">the meeting\u2019s SVINnovation session<\/a>.<\/p>\n<p>SoundPass co-founder Matt Findlay (University of Utah, Salt Lake City, USA) presented his team\u2019s technology to the panel at SVIN 2024, stating that it was predicated on the idea that \u2018two passes are too many\u2019 when it comes to EVD catheter access for neurosurgical drainage of cerebrospinal fluid (CSF).<\/p>\n<p>With the addition of an ultrasound transducer component at its tip, the SoundPass catheter is designed to provide real-time visualisation and\u2014by minimising the number of required passes\u2014ultimately reduce the likelihood of complications during EVD placement procedures. Findlay and his colleagues anticipate that this will help to add a new level of precision within a neurosurgical operation that is among the most common in the USA, but is typically performed \u2018blindly\u2019 without imaging guidance.<\/p>\n<p>As the winner of the SVINnovation grand prize, Findlay and the SoundPass team took home US$75,000\u00a0in cash in addition to\u00a0US$25,000\u00a0in complimentary consulting services and mentorship from industry experts at Brainstorme, Project Medtech, and Medical Device Global Regulatory Consulting (MCRA). SoundPass will also gain exposure in the journal <em>Stroke: Vascular and Interventional Neurology<\/em> and on the SVIN\u2019s website in the coming weeks.<\/p>\n<p>\u201cWe are deeply honoured and thrilled to receive the SVINnovation prize. We extend our sincere gratitude to the SVIN, its members, and the judges, for recognising our work. In the fast-paced world of startups, maintaining momentum is vital, and this funding will significantly accelerate our efforts to bring this innovative device to patients’ bedsides,\u201d Findlay told <em>NeuroNews<\/em>. \u201cThe funding will play a pivotal role in advancing our next major milestones, including cadaver and live animal studies to refine and validate our working prototypes. These crucial steps will not only accelerate our progress but also bring us closer to delivering life-changing solutions to patients.\u201d<\/p>\n<p>Presenting the award to Findlay following the judging panel\u2019s decision, VonVascular.io chief executive officer (CEO) Manning Hanser cited the SoundPass team\u2019s \u201cclear and easy\u201d proposed pathway to US Food and Drug Administration (FDA) 510(k) clearance, and praised the single-use nature of the device as well as the fact that it targets novice users and experienced neurosurgeons alike. Hanser also said he hopes the funds will enable the group to grow and add new areas of expertise to its \u201cawesome\u201d academic team.<\/p>\n<p>The first of three other novel concepts presented during the SVINnovation session was Quantanosis.ai. Showcased by its co-founder Ameer Hassan (Valley Baptist Medical Center, Harlingen, USA) at SVIN 2024, the company\u2019s technology intends to use artificial intelligence (AI)-powered diagnostics and a head-mounted helmet to break up neurovascular clots quickly and accurately\u2014but also completely non-invasively\u2014via histotripsy. With this operator-independent and portable solution, Quantanosis.ai\u2019s goal is to \u201cdemocratise\u201d stroke treatment.<\/p>\n<p>Following this, Shashvat Desai (HonorHealth, Scottsdale, USA) outlined the potential of a two-pronged solution to the global burden of hypertension. The technology in question incorporates an endovascular stent-like device capable of continuously monitoring intra-arterial blood pressure (SomaSense), and an electronic system designed to modulate the carotid sinus and control pressure levels in response to these monitoring data (SomaSafe). Desai concluded by noting that this proactive, real-time, personalised technology could improve compliance to treatment of \u201cthe worst disease mankind suffers from\u201d.<\/p>\n<p>Neuronics Medical CEO and co-founder Radoslav Raychev (University of California Los Angeles [UCLA] Health, Los Angeles, USA) gave the session\u2019s fourth and final pitch, showcasing his company\u2019s FAST.AI smartphone application\u2014which utilises machine learning algorithms with the goal of autonomously yet reliably detecting patients\u2019 physical signs of stroke. With the technology <a href=\"https:\/\/neuronewsinternational.com\/smartphone-app-reliably-and-autonomously-recognises-physical-stroke-signs-in-study\/\">having already demonstrated promising preliminary results<\/a> in a real-world study, Raychev\u2019s hope is that FAST.AI can detect signals like\u00a0facial asymmetry, arm weakness and speech changes with accuracy comparable to an actual neurologist\u2019s clinical impression.<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>A novel catheter intended to improve on the tools currently available in neurosurgical external ventricular drain (EVD) placement was awarded a US$100,000 grand prize at this year\u2019s Society of Vascular and Interventional Neurology (SVIN) annual meeting (20\u201322 November, San Diego, USA). The SoundPass device\u2014conceived and developed by a team of medical students from the University […]<\/p>\n","protected":false},"author":5277,"featured_media":13578,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[2469,909,2802,1986,1582,337,2805,2803,2804,2801,2778,205],"class_list":["post-13576","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-latest-news","tag-access-catheters","tag-csf","tag-evd","tag-fast-ai","tag-innovation","tag-neurosurgery","tag-novel-technology","tag-quantanosis-ai","tag-somasafe","tag-soundpass","tag-svin-2024","tag-ultrasound"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Novel EVD catheter scoops US$100,000 SVINnovation prize<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/novel-evd-catheter-scoops-us100000-svinnovation-prize\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novel EVD catheter scoops US$100,000 SVINnovation prize\" \/>\n<meta property=\"og:description\" content=\"A novel catheter intended to improve on the tools currently available in neurosurgical external ventricular drain (EVD) placement was awarded a US$100,000 grand prize at this year\u2019s Society of Vascular and Interventional Neurology (SVIN) annual meeting (20\u201322 November, San Diego, USA). The SoundPass device\u2014conceived and developed by a team of medical students from the University […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/novel-evd-catheter-scoops-us100000-svinnovation-prize\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-06T13:13:44+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/svinnovation-prize-money-pic-featured.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"766\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jamie Bell\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@NN_publishing\" \/>\n<meta name=\"twitter:site\" content=\"@NN_publishing\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jamie Bell\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/neuronewsinternational.com\/novel-evd-catheter-scoops-us100000-svinnovation-prize\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/neuronewsinternational.com\/novel-evd-catheter-scoops-us100000-svinnovation-prize\/\"},\"author\":{\"name\":\"Jamie Bell\",\"@id\":\"https:\/\/neuronewsinternational.com\/#\/schema\/person\/4147c89f885aa18c2336349a6be67cf3\"},\"headline\":\"Novel EVD catheter scoops US$100,000 SVINnovation 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LATE trial gets US$7 million funding boost to evaluate stroke thrombectomy beyond 24 hours"},"content":{"rendered":"<figure id=\"attachment_13572\" aria-describedby=\"caption-attachment-13572\" style=\"width: 220px\" class=\"wp-caption alignleft\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-13572\" src=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Amrou-Sarraj-thumbnail.jpg\" alt=\"\" width=\"220\" height=\"279\" \/><figcaption id=\"caption-attachment-13572\" class=\"wp-caption-text\">Amrou Sarraj<\/figcaption><\/figure>\n<p><strong>University Hospitals (UH) Cleveland Medical Center in Cleveland, USA has been awarded US$7 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to evaluate <a href=\"https:\/\/neuronewsinternational.com\/tag\/thrombectomy\/\" target=\"_blank\" rel=\"noopener\">endovascular thrombectomy<\/a> in patients presenting more than 24 hours from time last known well via the global SELECT LATE clinical trial. Amrou Sarraj (UH Neurological Institute, Cleveland, USA) will lead the study, which aims to provide deterministic evidence of a clinical benefit with the addition of thrombectomy to standard medical care in this patient population.<\/strong><\/p>\n<p>Sarraj and colleagues will conduct the study across sites in the USA, Canada, Europe, Australia and New Zealand, assessing the benefits and risks of thrombectomy for patients who present to the hospital beyond the usual 24-hour timeframe for treatment by randomly assigning them to receive either thrombectomy or standard medical care. The researchers will compare how well patients in each group respond in terms of functional independence\u2014as per ability to perform day-to-day tasks without help from others\u2014and quality of life as identified by the patients.<\/p>\n<p>Based on <a href=\"https:\/\/www.heart.org\/en\/professional\/quality-improvement\/get-with-the-guidelines\/get-with-the-guidelines-stroke\" target=\"_blank\" rel=\"noopener\">Get With The Guidelines<\/a> data, only about 10% of patients presenting with a large vessel occlusion later than 24 hours currently receive thrombectomy treatment.<\/p>\n<p>\u201c[The] thrombectomy procedure has revolutionised how we treat patients with acute ischaemic stroke due to occlusion in one of the larger brain vessels,\u201d said Sarraj, principal investigator for the SELECT LATE trial. \u201cHowever, the current evidence of efficacy and safety is limited to those presenting within 24 hours of when they were last known to be without symptoms. For patients who present beyond this timeframe, a lack of randomised evidence prevents us from treating them universally with this state-of-the-art technology that is shown to improve stroke outcomes by two to three folds. We expect this to help many patients; those who live alone without early recognition of their symptoms, especially the elderly, and patients who do not have prompt access to thrombectomy centres.\u201d<\/p>\n<p>The trial aims to reduce treatment disparities in elderly patients who live alone, and also those living in rural and remote communities. These patients often do not have timely access to healthcare, resulting in delayed presentation and potential disqualification from receiving this treatment.<\/p>\n<p>Following the recent success of Sarraj and colleagues\u2019 <a href=\"https:\/\/neuronewsinternational.com\/select2-thrombectomy-large-core-stroke-isc-2023\/\" target=\"_blank\" rel=\"noopener\">SELECT2 trial<\/a>\u2014which established efficacy and safety of thrombectomy in patients presenting with large strokes\u2014Nicholas Bambakidis (UH Neurological Institute, Cleveland, USA) feels this is the next step in the evolution of acute stroke management.<\/p>\n<p>\u201cUniversity Hospitals and Case Western Reserve University [Cleveland, USA] have always been at the forefront of medical advances,\u201d Bambakidis stated. \u201cThe SELECT LATE global trial will have a tremendous impact on acute stroke management, not only individually but also in terms of how we organise stroke systems of care.\u201d<\/p>\n<p>“We expect a major impact on systems of care and the current patients’ transfer practice, since these patients are vastly not being considered for transfer [to a] higher level of care and consideration of thrombectomy,\u201d Sarraj added.<\/p>\n<p>\u201cThis project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other healthcare stakeholders, but also for its conduct in real-world settings,\u201d said PCORI executive director Nakela Cook. \u201cIt has the potential to answer an important question about the utility of endovascular thrombectomy in this vulnerable patient population and fill a crucial evidence gap. We look forward to following the study\u2019s progress and working with University Hospitals Cleveland Medical Center to share its results.\u201d<\/p>\n<p>The SELECT LATE study was selected through PCORI\u2019s competitive review process in which patients, caregivers and other stakeholders join scientists to evaluate proposals. Sarraj and colleagues\u2019 award has been approved pending completion of PCORI\u2019s business and programmatic review, and issuance of a formal award contract.<\/p>\n<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div>","protected":false},"excerpt":{"rendered":"<p>University Hospitals (UH) Cleveland Medical Center in Cleveland, USA has been awarded US$7 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to evaluate endovascular thrombectomy in patients presenting more than 24 hours from time last known well via the global SELECT LATE clinical trial. Amrou Sarraj (UH Neurological Institute, Cleveland, USA) will […]<\/p>\n","protected":false},"author":5277,"featured_media":13574,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[1043,790,376,2800,25],"class_list":["post-13571","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-latest-news","tag-evt","tag-funding","tag-large-vessel-occlusion-stroke","tag-select-late","tag-thrombectomy"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>SELECT LATE trial gets US$7 million funding boost to evaluate stroke thrombectomy beyond 24 hours<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/neuronewsinternational.com\/select-late-trial-gets-us7-million-funding-boost-to-evaluate-stroke-thrombectomy-beyond-24-hours\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SELECT LATE trial gets US$7 million funding boost to evaluate stroke thrombectomy beyond 24 hours\" \/>\n<meta property=\"og:description\" content=\"University Hospitals (UH) Cleveland Medical Center in Cleveland, USA has been awarded US$7 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to evaluate endovascular thrombectomy in patients presenting more than 24 hours from time last known well via the global SELECT LATE clinical trial. Amrou Sarraj (UH Neurological Institute, Cleveland, USA) will […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/neuronewsinternational.com\/select-late-trial-gets-us7-million-funding-boost-to-evaluate-stroke-thrombectomy-beyond-24-hours\/\" \/>\n<meta property=\"og:site_name\" content=\"NeuroNews International\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/NeuroNews\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-04T14:07:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/neuronewsinternational.com\/wp-content\/uploads\/sites\/3\/2024\/12\/Amrou-Sarraj-featured.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"766\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jamie Bell\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" 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