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Total 237 results found since Jan 2013.
NIH inks $5m partnership with PathMaker Neurosystems for MyoRegulator spasticity device
PathMaker Neurosystems said today it signed a $5 million cooperative partnership deal with the National Institutes of Health to support continued development of its MyoRegulator neurostimulation system designed to treat spasticity secondary to stroke.
The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston and Paris-based company said.
The money comes as part of a four-year grant awarded through the CREATE Devices program which also provides a partnership with the NIH’s National Institute of ...
Source: Mass Device - February 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation PathMaker Neurosystems Inc. Source Type: news
J & J ’ s Cerenovus launches Galaxy G3 mini embolic coil, touts Arise II Embotrap study data
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus division this week announced the launch of its Galaxy G3 Mini embolic coil and released data from a study of its Embotrap device designed to remove clots from the brain following ischemic stroke.
The Galaxy G3 Mini coils are designed to be approximately 25% softer than the Galaxy G3 xsft coils, with an ultra-low coil profile and a primary wind diameter of 0.009 inches, which Cerenovus said is the lowest profile available in its Spectra line.
The newly launched coil is designed to have a random complex shape to make it comformable and enable the device to seek and fill open...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Catheters Clinical Trials Neurological Vascular cerenovus johnsonandjohnson Source Type: news
Stryker touts post-market Wingspan stent trial results
Stryker (NYSE:SYK) today released results from the post-market Weave trial of its Wingspan stent system designed for treating intracranial atherosclerotic disease.
Data from the study was presented at the International Stroke Conference, the Kalamazoo, Mich.-based company said.
The Weave trial is a multi-center, prospective, post-market surveillance study which aimed to evaluate rates of stroke or death within 72 hours in patients treated with the Wingspan stent system.
Results from the FDA-mandated trial indicated that patients receiving treatment with the Wingspan stent system had a 2.6% rate of stroke or death, lower ...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stents Vascular Stryker Source Type: news
Penumbra touts real-world study results in Penumbra System acute ischemic stroke trial
Penumbra (NYSE:PEN) today released results from the Promise real-world safety and efficacy study of its Penumbra System with ACE 68 and 64 reperfusion catheters as a treatment for patients with acute ischemic stroke, touting high rates of revascularization and low rates of all-cause mortality.
Results were presented at the International Stroke Conference this week in Los Angeles.
“We thank the Promise investigators for this important contribution to the growing body of global evidence supporting Adapt as a frontline approach for patients with acute ischemic stroke. The Promise study affirms our belief that the Penu...
Source: Mass Device - January 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Penumbra Inc. Source Type: news
J & J ’ s Biosense Webster launches WaveCrest study
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said today that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system.
The 1,250-patient study is designed to assess the safety and efficacy of the WaveCrest left atrial appendage occlusion system as a way to reduce the risk of embolic stroke in atrial fibrillation patients.
“The WaveCrest System is designed to enable physicians to close the heart’s LAA, where most stroke-causing blood clots occur,” Dr. Larry Chinitz, who treated the first patient in the trial at New York University Hospital, s...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials BioSense Webster Inc. johnsonandjohnson Source Type: news
LivaNova launches post-market study of bioprosthetic aortic heart valves
LivaNova (NSDQ:LIVN) announced today that the first patient has been enrolled in a post-market trial evaluating the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a bioprosthetic aortic heart valve.
Four-dimensional CT scans will be taken of the trial’s 230 participants at least 30 days after they stop anticoagulation or dual antiplatelet therapy, according to LivaNova. The study will also include one year of follow-up.
“Thrombus formation on valve leaflets has been shown to occur in some patients receiving prosthetic tissue valve replacement via transcatheter or ope...
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Imaging Wall Street Beat LivaNova Source Type: news
InspireMD touts 2-year CGuard EPS results
InspireMD (NYSE:NSPR) this week released two-year results from the Paradigm 101 clinical study of its CGuard embolic protection system.
Results from the trial were initially presented at the 2017 VEITH Symposium in New York last month.
In the investigator-led study, researchers examined the use of the CGuard EPS system in 101 patients with symptomatic or high-risk asymptomatic carotid artery stenosis. Data from the study indicated that there were no deaths, major stroke or myocardial infarctions as a result of periprocedural or postprocedural interventions at at two years.
InspireMD said that the results were consistent w...
Source: Mass Device - December 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological InspireMD Source Type: news
FDA clears AliveCor ’ s KardiaBand ECG for Apple Watch
AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation.
First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.
AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the ...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Patient Monitoring Wall Street Beat AliveCor Cardiac Rhythm Management Source Type: news
Stryker touts NEJM publication of Trevo thrombectomy device trial results
Stryker (NYSE:SYK) yesterday released results from the Dawn trial of its Trevo thrombectomy device, touting significant effects even when used beyond six hours after stroke.
Results from the trial were published in the New England Journal of Medicine, the Kalamazoo, Mich.-based company said.
“By quadrupling the size of the therapeutic time window, the consequence of Dawn is that many more patients with large vessel occlusion stroke have the potential to be treated with mechanical thrombectomy. Dawn validates the physiological, rather than time-based approach to patient selection for endovascular therapy,” co...
Source: Mass Device - November 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Stryker Source Type: news
Stryker wins FDA HDE nod or Neuroform Atlas wide-neck aneurysm stent
Stryker (NYSE:SYK) said today it won humanitarian device exemption from the FDA for its Neuroform Atlas stent system designed to be used with neurovascular embolic coils to treat wide neck, intracranial, saccular aneurysms.
The newly HDE-cleared Neuroform Atlas is a nitinol stent designed to be used with metal coils to pack aneurysms in the brain.
The system is positioned through a small tube and delivered across the neck of the aneurysm to support and pack it, the company said. Wide neck aneurysms are estimated to represent less than 10% of unruptured aneurysms treated.
“The Neuroform Atlas Stent System is the mos...
Source: Mass Device - November 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Stents Vascular Stryker Source Type: news
Medtronic wins CE Mark for Intellis SCS, PNS systems
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Intellis spinal cord stimulation and peripheral nerve stimulation systems designed to treat chronic pain.
The Fridley, Minn.-based company touted the Intellis as the world’s smallest fully implantable SCS neurostim. The newly-cleared system includes improved battery performance and is managed through the use of a Samsung Galaxy Tab S2 tablet.
“Medtronic’s goal is to simplify treatment and improve the patient experience with personalized therapy that provides long-term pain relief and helps restore function. The launch ...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neuromodulation/Neurostimulation Pain Management Regulatory/Compliance Medtronic Source Type: news
TCT 2017: Boston Scientific touts lowered hemorrhagic stroke rate, cost for patients in Watchman studies
Boston Scientific (NYSE:BSX) today released combined 5-year outcomes data from both the Prevail and Protect-AF study of its Watchman left atrial appendage closure device, touting it as a safe and effective an alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation.
Five-year data from the Prevail study was published online today in the Journal of the American College of Cardiology.
In both trials, the Marlborough, Mass.-based company compared the Watchman device to warfarin treatment for stroke prevention in patients with non-valvular AF with follow-ups out to five years. A combined an...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke.
Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes.
Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11.7%, Medt...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news
TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR
Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver.
Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT.
One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group analysi...
Source: Mass Device - October 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news
TCT 2017: Abbott ’s Xience coronary stent helps patients feel better faster than open-heart surgery
Abbott (NYSE:ABT) reported today that patients who were treated with the company’s Xience coronary stent for left-main coronary artery disease felt better faster compared to patients who had open-heart surgery.
The data were presented at this year’s Transcatheter Cardiovascular Therapeutics meeting during a late-breaking session.
“For any treatment, it’s important to not only consider clinical outcomes such as recurrent heart attacks or stroke, but also to consider the effect of the treatment on a patient’s quality of life,” study investigator Dr. Suzanne Baron said in prepared remarks.
Get ...
Source: Mass Device - October 30, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Surgical Wall Street Beat Abbott Source Type: news
