Tag: SCS
Boston announces clinical data from chronic pain portfolio at ASPN 2024
Boston Scientific Corporation has announced the presentation of positive five-year pooled results for the Intracept intraosseous nerve ablation system, measuring outcomes across three clinical...
SpineX closes recruitment for trial evaluating Scone SCS technology in neurogenic...
SpineX has closed recruitment for the CONTINENCE clinical trial of its proprietary Scone device. The study began back in May 2022 and is evaluating...
Boston’s WaveWriter SCS systems gain expanded non-surgical back pain indication from...
Boston Scientific Corporation announced today that the US Food and Drug Administration (FDA) has approved an expanded indication of the company’s WaveWriter spinal cord...
Nevro to highlight 25 scientific abstracts on spinal cord stimulation at...
Nevro Corporation has announced a series of data presentations supporting the use of the company's high-frequency (HFX) 10kHz spinal cord stimulation (SCS) therapy for...
Boston Scientific to present late-breaking data at NANS 2024
Boston Scientific Corporation has announced its clinical data that will be featured at the upcoming North American Neuromodulation Society (NANS) annual meeting (18–21 January,...
Washington state “poised” to extend spinal cord stimulation coverage following straw...
As per a recent statement from the North American Neuromodulation Society (NANS), the US state of Washington may be about to extend its insurance...
Nalu announces positive results from spinal cord stimulation nPower US clinical...
Nalu Medical has announced the publication of the spinal cord stimulation (SCS) nPower US clinical study in the Pain Physician Journal, reporting on clinical outcomes...
SpineX announces new report on SCS improving bladder function in stroke...
SpineX has reported in a press release that a publication titled, “A pilot study of the effect of transcutaneous spinal cord stimulation on micturition-related...
Medical necessity “should drive all remote monitoring decisions” in SCS, expert...
The principle of medical necessity “should drive all remote monitoring decisions” relating to spinal cord stimulation (SCS) technologies, according to recommendations recently published in...
NANS leads multi-society response to “methodologically flawed” SCS re-review in Washington...
The North American Neuromodulation Society (NANS) has led a multi-society response to the Washington State Health Care Authority (WSHCA) following its review of the...
Saluda receives US FDA approval for MRI labelling of Evoke spinal...
Saluda Medical has announced that the US Food and Drug Administration (FDA) has approved magnetic resonance imaging (MRI) conditional labelling for its Evoke system,...
Nalu presents new study data on pain management with PNS and...
Nalu Medical, a company that has miniaturised neurostimulation implants for the management of chronic intractable pain for both peripheral nerve stimulation (PNS) and spinal...
Education and collaboration key to continued advancement of painful diabetic neuropathy...
The neuromodulation space has proliferated significantly over the past few years, and one area in which this is most notable is with the expansion...
Cochrane Library urged to retract and revise recent SCS review over...
Pain physicians have urged the Cochrane Library to retract and revise a recent review of spinal cord stimulation (SCS) in the treatment of low...
Abbott announces expanded MRI labelling for Eterna spinal cord stimulation system
Abbott has announced that the US Food and Drug Administration (FDA) has approved expanded magnetic resonance imaging (MRI) labelling for its Eterna spinal cord...
Biotronik announces US FDA approval of Prospera spinal cord stimulation system
Biotronik has announced US Food and Drug Administration (FDA) approval for Prospera—a new spinal cord stimulation (SCS) system. The system features RESONANCE, which the...
Review concludes SCS benefits do not outweigh associated risks and costs...
A recently published Cochrane review has concluded that the clinical benefits of spinal cord stimulation (SCS) do not outweigh the risks and costs associated...
Nevro announces full US market launch of HFX iQ spinal cord...
Nevro Corporation announced today that it has now initiated the full US market launch of its HFX iQ spinal cord stimulation (SCS) system, following...
High-frequency spinal cord stimulation may be associated with “significant decrease” in...
High-frequency spinal cord stimulation (HF-SCS) for treating chronic refractory low back pain (CRLBP) may be associated with a significant decrease in total healthcare costs,...
SCS therapies can play a role in cancer-related pain treatment despite...
Spinal cord stimulation (SCS) therapies targeting the dorsal column “may be considered” within the multimodal treatment plans typically required by cancer patients, but it...
Boston Scientific announces three-month data from SOLIS trial at NANS
Combination spinal cord stimulation (SCS) therapy with Boston Scientific’s WaveWriter system has demonstrated superior outcomes to conventional medical management (CMM) in chronic pain patients...
Abbott gains US FDA approval for SCS therapy in painful diabetic...
Abbott has announced that the US Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful...
Abbott presents new data on streamlining patient-reported measures, BurstDR and more...
Abbott presented new data in more than 30 presentations and posters at the North American Neuromodulation Society (NANS) annual meeting (12–15 January 2023, Las...
Medtronic to highlight sensing-enabled spinal cord stimulation research at NANS 2023
Medtronic has announced that it will highlight clinical and preclinical research relating to sensing-enabled spinal cord stimulation (SCS) therapy at the North American Neuromodulation...
Saluda Medical initiates US commercialisation of Evoke spinal cord stimulation system
Saluda Medical has announced plans for a limited commercial release of its Evoke spinal cord stimulation (SCS) system in the USA, with a full commercial...
Intraoperative neuromonitoring may drive a new era in spinal cord stimulation...
“We are entering an era where true scientific evidence from IONM is guiding technology and our clinical practice.” This was one of the...
Abbott to receive multiple CES 2023 awards for neurostimulation and pacemaker...
Abbott has been recognised by the Consumer Technology Association (CTA) with three Consumer Electronics Show (CES 2023; 5–8 January, Las Vegas, USA) Innovation Awards...
Nevro announces US FDA approval of HFX iQ system to personalise...
Nevro Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS)...
Onward reports positive study results in restoring arm and hand function...
Onward Medical recently announced that the Up-LIFT pivotal study evaluating its non-invasive spinal cord stimulation (SCS) ARC-EX therapy achieved its primary effectiveness endpoint of...
Nevro announces positive coverage updates for treatment of painful diabetic neuropathy...
Nevro Corporation has announced that US health plan Aetna has updated its spinal cord stimulation (SCS) coverage policy to explicitly cover painful diabetic neuropathy...
Gimer Medical granted IDE approval for spinal cord stimulation system
Gimer Medical today announced that the company’s spinal cord stimulation (SCS) system was granted conditional investigational device exemption (IDE) approval by US Food and...
Abbott gains US FDA approval for Proclaim Plus spinal cord stimulation...
Abbott has announced that the US Food and Drug Administration (FDA) has approved its new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360...
Saluda Medical presents data on 24-month holistic response to spinal cord...
Saluda Medical has announced that Steven Falowski (Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, USA) recently presented late-breaking 24-month data from the company’s EVOKE study at...
High-frequency SCS demonstrates “substantial improvement” in health-related quality of life outcomes
Nevro Corporation has announced that the complete 12-month results from the SENZA-PDN randomised controlled trial (RCT), including health-related quality of life outcomes in patients with...
High responder rates, substantial pain relief and no explants among key...
Nevro Corporation has announced the results from data presentations at the American Diabetes Association (ADA) 82nd Scientific Sessions (3–7 June 2022, New Orleans, USA) supporting the use of...
Nevro announces upcoming presentation of new SENZA-PDN clinical data
Nevro Corporation has announced that data from the SENZA painful diabetic neuropathy (PDN) randomised controlled trial (RCT)—which the company says is the largest RCT to...
INS 2022: Dorsal horn dendrite stimulation offers “true breakthrough” in pain...
A novel approach to spinal cord stimulation (SCS), which involves targeting the dorsal horn dendrite—in contrast with more traditional ‘axonal’ SCS techniques—has been labelled...
Recommended use of SCS in neuropathic pain has not led to...
Only a small proportion of neuropathic pain patients in England who are potentially eligible for spinal cord stimulation (SCS) have received this intervention over...
Saluda Medical raises US$125 million to boost Evoke spinal cord stimulation...
Saluda Medical has finalised US$125 million in equity financing, with the proceeds being used in part to operationalise and scale commercialisation of the company’s Evoke spinal...
High-frequency SCS drives impactful outcomes for non-surgical refractory back pain patients
Following the recent introduction of key data supporting the use of high-frequency spinal cord stimulation (SCS) in the treatment of non-surgical refractory back pain...
Saluda Medical receives FDA approval for Evoke SCS system to treat...
Saluda Medical has announced that it has received full approval from the US Food and Drug Administration (FDA) for the Evoke spinal cord stimulation (SCS)...
Multiple-modality spinal cord stimulation demonstrates sustained improvement in chronic pain outcomes
A spinal cord stimulation (SCS) system capable of simultaneously delivering multiple treatment modalities has produced a sustained improvement in outcomes in a randomised controlled...
NeuroOne releases successful completion of long-term stimulation tests with novel, thin-film...
NeuroOne Medical Technologies has announced that it successfully completed initial, bench-top, long-term stimulation testing on a novel design of its thin-film electrode technology. The...
Nevro announces publication of 12-month data on high-frequency SCS for non-surgical...
Nevro Corporation has announced online publication of 12-month data from the SENZA-NSRBP randomised controlled trial (RCT) in Journal of Neurosurgery: Spine. These data show that...
NANS 2022: New 18-month data show durability of high-frequency SCS for...
This year’s North American Neuromodulation Society (NANS) annual meeting (13–15 January 2022; Orlando, USA) saw 18-month data from SENZA-PDN—a randomised controlled trial (RCT) evaluating the...
Medtronic announces FDA approval of SCS therapy for diabetic peripheral neuropathy
Medtronic has received US Food and Drug Administration (FDA) approval of its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for the treatment of chronic...
Nevro announces clinical data reinforcing significant and durable benefits of 10kHz...
Nevro Corporation has announced the results from data presentations at the 25th North American Neuromodulation Society (NANS) annual meeting (13–15 January 2022; Orlando, USA) supporting...
Medtronic announces results showing meaningful pain relief using DTM SCS endurance...
Medtronic has announced three-month results from an on-label, prospective, multicentre study showing meaningful pain relief using DTM SCS endurance therapy—a modified, lower-energy variation of the...
FDA grants Breakthrough Device designation to Wavegate for StimuLux system
Wavegate Corporation has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for its StimuLux optical reflectometry system for closed-loop...
Saluda announces sustained, long-term pain relief results with closed-loop SCS in...
Saluda Medical today announced long-term results from its double-blind, Level 1 EVOKE trial, which have been published in JAMA Neurology and demonstrate superior, sustained pain...
Boston Scientific to present new data on advances in chronic pain...
Boston Scientific has announced key data that will be featured at the 25th North American Neuromodulation Society (NANS) annual meeting (13–15 January 2022; Orlando, USA)....
Abbott announces expanded MRI compatibility for Proclaim XR spinal cord stimulation...
Abbott has announced that the US Food and Drug Administration (FDA) has approved new, expanded magnetic resonance imaging (MRI) compatibility for its Proclaim XR spinal cord...
Current gaps and barriers in patient access to spinal cord stimulation
Maricela Schnur (St Luke’s Hospital, Duluth, USA) highlights a handful of socioeconomic disparities, racial differences, and psychological and psychiatric factors, that currently present difficulties...
Antibiotic envelopes appear safe and effective in decreasing SCS surgical site...
Antibiotic impregnated envelopes appear to be a safe and effective modality for decreasing surgical site infection risks in spinal cord stimulation (SCS) implantation, according...
Nevro announces plans to appeal jury decision in spinal cord stimulation...
Nevro Corporation has provided an update on its position following a Delaware jury’s decision to award Boston Scientific US$20 million over patent infringements. The...
NeoSpine first to offer spinal cord stimulation for treatment of painful...
NeoSpine is now offering spinal cord stimulation (SCS) procedures for the treatment of painful diabetic neuropathy (PDN) via its HFX system—a newly approved nondrug treatment...
High-frequency SCS takes the stage to relieve chronic pain from diabetic...
Following the recent approval of the Senza system (Nevro) by the US Food and Drug Administration (FDA), Erika A Petersen (Little Rock, USA) discusses the...
CRISP study indicates clinical benefit of non-paraesthesia-based approaches in burst SCS...
The CRISP (Comparison of paraesthesia mapping to anatomic midline-based burst programming strategies) study, published in Neuromodulation: Technology at the Neural Interface, has found that...
Boston Scientific launches FAST—a new therapy for spinal cord stimulation
Boston Scientific has announced the European launch of FAST—a new, fast-acting sub-perception therapy that the company says is clinically proven to demonstrate significant and...
Presidio Medical publishes clinical and preclinical research on ULF neuromodulation therapy
Presidio Medical has announced that research involving its novel ultra-low frequency (ULF) neuromodulation therapy has been published in Science Translational Medicine. The publication, titled...
DTM SCS: A unique, tailored and highly effective therapy option for...
Michael Fishman (Wilmington, USA) discusses the benefits of Differential Target Multiplexed spinal cord stimulation (DTM SCS; Medtronic)—when compared to more conventional SCS therapy options—and...
Temporary SCS could represent “new paradigm” in preventing atrial fibrillation
In a randomised pilot study, temporary spinal cord stimulation (SCS) has demonstrated efficacy in the suppression of postoperative atrial fibrillation (AF) following coronary artery...
Nevro announces FDA approval of 10kHz high-frequency SCS therapy for painful...
Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system for the treatment of chronic pain associated with...
Medtronic announces FDA approval of recharge-free Vanta spinal cord stimulation implant
Medtronic has received US Food and Drug Administration (FDA) approval for Vanta—a high-performance, recharge-free implantable neurostimulator (INS) with a device life that can be...
Up to 13% of patients could have their spinal cord stimulator...
According to a study published in Neuromodulation, five years after implantation, spinal cord stimulators have been explanted in 13.5% of patients. Furthermore, about 10%...
Burst spinal cord stimulation improves psychosocial outcomes and reduces opioid usage...
A study investigating chronic pain sufferers treated with burst spinal cord stimulation (B-SCS) has concluded that improvements were observed among all psychological measures at...
Educational curriculum for spinal cord stimulation developed to fill “unmet need”
A spinal cord stimulation (SCS) training curriculum has been developed by a multidisciplinary taskforce of the North American Neuromodulation Society’s (NANS) education committee. It...
Novel intermittent dosing burst spinal cord stimulation deemed safe and efficacious...
A novel intermittent dosing burst paradigm in spinal cord stimulation (SCS) has effectively relieved pain in patients with chronic intractable pain. Authors Timothy Deer,...
New study finds high responder rates for ECAP-controlled, closed-loop spinal cord...
A randomised, double-blind trial finds ECAP-controlled closed-loop spinal cord stimulation (SCS) statistically superior for the treatment of chronic pain, compared to open-loop stimulation. At...
Saluda Medical results of US Evoke pivotal study through 12 months...
Saluda Medical has announced The Lancet Neurology journal published results from the US pivotal study demonstrating its Evoke ECAP-controlled, closed-loop spinal cord stimulation (SCS)...
Nevro announce launch of a new medical device for the treatment...
Nevro today announced it has received approval from the US Food and Drug Administration (FDA) for the Senza Omnia spinal cord stimulation (SCS) system....
FDA approves low-dose spinal cord stimulator for chronic pain
Abbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim...
Saluda Medical announces European commercial launch of Evoke, the ECAP-controlled, closed-loop...
Saluda Medical has announced the award of CE mark and the European commercial launch of the Evoke ECAP-controlled, closed-loop spinal cord stimulation (SCS) system...
Low pain scores following spinal cord stimulation trials found predictive of...
Low pain scores after spinal cord stimulation (SCS) trials are predictive of successful SCS implants with high sensitivity, according to a recent study. The...
The clinical utility of evoked compound action potentials is echoed by...
New data from both the Evoke and Avalon studies reiterate the importance of objective neurophysiological measures and clinically meaningful outcomes. These studies evaluated the...
Nevro announces completion of patient enrolment in multicentre RCT of high...
Nevro has announced that it has completed patient enrolment in its prospective, multicentre randomised controlled trial (RCT) for the treatment of chronic pain for...
Similar success rates for anatomic and targeted lead placement for spinal...
“Anatomical lead placement is a viable alternative to targeted lead placement for spinal cord stimulation,” concluded Jason E Pope, Evolve Restorative Center, Santa Rosa,...
The first wireless spinal cord stimulator system elicits a high response...
A study evaluating different waveforms within a wireless spinal cord stimulator (SCS) device (Stimwave) has found high response rates for patients receiving both high...
Placebo-controlled RCTs of spinal cord stimulation are on the rise, but...
Important methodological aspects of clinical trials of spinal cord stimulation (SCS) using a placebo are consistently being poorly reported, says a recent systematic review....
Key findings from a review of the indications, complications, and incidence...
A retrospective database review of 12,297 spinal cord stimulator (SCS) patients outlines key findings concerning the indications, incidence of minor and major complications, and...
Abbott partners with NIH on BRAIN initiative to advance research for...
Abbott have announced that it has partnered with the National Institutes of Health (NIH) on the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) initiative...
Stimwave announces publication of 10 kHz Freedom Stimulator SURF RCT results
Stimwave has announced publication of the results of the first ever randomised, controlled trial (RCT) comparing wireless high-frequency (HF: 10 kHz) spinal cord stimulation...
Novel differential-target multiplexed technique outperforms conventional SCS
Continuous differential-target multiplexed (DTM) spinal cord stimulation (SCS) provides better thermal and mechanically induced pain relief compared to high-rate and low-rate SCS, concluded Ricardo...
Evoke: The first RCT to measure spinal cord activations in response...
The protocol design for a multicentre, prospective, randomised, double-blind study comparing ECAP- (evoked compound action potential) controlled closed-looped with open-loop, fixed output spinal cord...
Majority of radiculopathy patients prefer burst to conventional tonic stimulation
BurstDR stimulation confers a greater reduction in leg and back pain intensity on patients with failed back surgery syndrome that tonic stimulation does, a...
Nuvectra receives full-body MR-conditional CE Mark approval for Algovita
Nuvectra has announced that it has received full-body MR-conditional approval for the Company’s Algovita spinal cord stimulation (SCS) system from its European Notified Body,...
Nuvectra receives FDA head-only MR-conditional approval for Algovita
Nuvectra has announced that it has received US Food and Drug Administration (FDA) head-only MR-conditional approval for the company’s Algovita spinal cord stimulation (SCS) system.
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