Across October and November, our readers were drawn to everything from recent shifts in neurovascular device regulation, to “failures of the peer-review process” in intracranial aneurysm literature, to the latest major trial supporting thrombectomy for large-infarct ischaemic strokes. Among other top stories on NeuroNews were an in-depth discussion with the outgoing Society of Vascular and Interventional Neurology (SVIN) president and an exclusive video interview on the “next evolution” in intrasaccular systems.
1. “The tables have turned”—US FDA regulation is becoming the envy of Europe
Discussions at this year’s European Society of Minimally Invasive Neurological Therapy (ESMINT) congress (4–6 September, Marseille, France) revealed the extent of the disparities between the current regulatory systems in Europe and the USA, with experts and attendees outlining how “the tables have turned” over the past few years, potentially enticing more neurovascular device manufacturers to seek US Food and Drug Administration (FDA) clearance as their first port of call.
2. Current intracranial aneurysm literature reflects “a failure of the peer-review process”
A systematic review and meta-analysis of 1,356 studies and more than 410,000 patients have found that “methodological flaws and incomplete reporting” occur frequently in studies advocating the safety, effectiveness or durability of intracranial aneurysm treatments—forming a “potential public health hazard” for patients and, in the view of the authors, a “failure of the peer-review process”.
3. Rapid Medical announces enrolment of final patient in post-market SUCCESS study
Rapid Medical has announced that the final patient has been enrolled in SUCCESS—a US FDA post-market surveillance study assessing the safety and performance of the company’s Comaneci embolisation assist device in the USA.
4. PROFILE: Ameer Hassan
Having initially sought out a career in plastic surgery, Ameer Hassan (Harlingen, USA) switched gears to interventional neurology in 2005—a change of heart he attributes to his “greatest mentor”—and never looked back. In addition to being triple board-certified in neurology, vascular neurology and neuroendovascular surgery, he is head of the Neuroscience Department and director of the Endovascular Surgical Neuroradiology and Clinical Neuroscience Research at Valley Baptist Medical Center, and is currently approaching the end of a two-year stint as SVIN president. In conversation with NeuroNews, he reflects on his career to date, and assesses ways of improving global access to critical stroke treatments.
5. Latest TRIAGE-STROKE and RACECAT data put the brakes on alternative stroke transfer protocols
Recently published data from two large randomised controlled trials (RCTs) have indicated there may be minimal benefits—or even negative effects—associated with bypassing local or primary stroke centres and transporting patients straight to thrombectomy-capable comprehensive stroke centres (CSCs). However, investigators are in agreement that additional research is required to further elucidate the impact of transferring stroke patients directly to CSCs.
6. VIDEO: Nautilus represents “next evolution” of intrasaccular systems in aneurysm care
The Nautilus system (Endostream Medical)—a self-conforming intrasaccular flow diverter intended for the treatment of intracranial aneurysms—heralds the “next evolution” in these types of neurovascular devices. That is according to J Mocco (New York, USA), who spoke to NeuroNews at this year’s ESMINT congress to discuss how the technology works and provide an update on clinical usage of the device to date.
7. TENSION results show improved functional outcomes and reduced mortality with stroke thrombectomy
New results from the TENSION study—presented recently at the 15th World Stroke Congress (WSC; 10–12 October, Toronto, Canada) by Götz Thomalla (Hamburg, Germany)—have demonstrated improved functional outcomes and reduced mortality rates among stroke patients treated via mechanical thrombectomy.
8. Anaconda Biomed granted additional patents for novel stroke thrombectomy technology
Anaconda Biomed has announced that the European Patent Office has granted the company a European patent for “A device and a thrombectomy apparatus for extraction of thrombus from a blood vessel”, published as patent number EP 3866708 B1 on 27 September 2023. In addition, patent number US 11,771,446 B2 was also granted to the company on 3 October 2023 for a method to improve the efficacy of removing cerebral vascular thrombi.
9. Perfuze enrols first stroke patient in MARRS pivotal trial of Millipede system
Perfuze has announced commencement of enrolment in its pivotal MARRS study—a multicentre trial set to evaluate the performance of aspiration thrombectomy with the company’s Millipede system for revascularisation in acute ischaemic stroke. The first patient was enrolled at Stony Brook University Hospital in Stony Brook, USA.
10. Upcoming technologies set to forebear “new era” in prehospital stroke care
While the latest thrombectomy techniques, thrombolytic drug candidates and even neuroprotective agents are the source of much discussion in today’s neurovascular space, there is also significant room for improvement within another step along the stroke care pathway: patient triage. For NeuroNews, Jeffrey Saver (Los Angeles, USA) provides a snapshot of the novel technologies being used to improve diagnoses, transfer decisions and, ultimately, patient outcomes.
