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Total 467 results found since Jan 2013.

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

FDA clears Medtronic ’ s Riptide clot aspiration device
Medtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its Riptide clot aspiration device for treating ischemic stroke. The Riptide device is designed to retrieve blood clots via the Arc catheter to restore blood flow to the brain. The clearance covers patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of first symptoms, including patients who can’t take or failed off of anti-clotting drugs. Medtronic called the Riptide design “a foundational platform” for other aspiration catheters it’s developing. The Fridley, M...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Neurological Medtronic Stroke 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

Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity
Medtronic (NYSE:MDT)  touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients with severe post-stroke spasticity. The medtech titan’s SynchroMed II pump is the only device approved in the U.S. for ITB therapy. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic touts therapy delivered via SynchroMed pump in patients with post-stroke spasticity appeared first on MassDevice.
Source: Mass Device - January 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Neurological Pharmaceuticals Wall Street Beat Medtronic Source Type: news

Why innovation isn ’t the key for treating stroke
Stacy Pugh, VP and general manager of Medtronic’s neurovascular unit Technology and innovation are not the most important things we can do for stroke, according to Stacey Pugh, VP and general manager of the neurovascular unit at Medtronic. The most important thing that could happen for stroke is passing proper legislation about taking patients in emergency situations to comprehensive stroke centers for proper treatment, Pugh explained during her keynote discussion at DeviceTalks West last month. Technology has changed, but systems of care have not. “The most important thing we can do today in stroke unfortunately isnâ...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Neurological DeviceTalks West MedTech Medtronic Source Type: news

Stroke treatment: There ’ s a simple way to improve it in the U.S.
Stacey Pugh, VP and general manager of Medtronic’s neurovascular unit Technology is already available to greatly improve outcomes for people suffering from strokes, but the present healthcare system is standing in the way of people getting it, according to Stacey Pugh, VP and general manager of the neurovascular unit at Medtronic. The most important thing that could boost stroke treatment is passing proper legislation about taking patients in emergency situations to comprehensive stroke centers for proper treatment, Pugh explained during her keynote discussion at DeviceTalks West last month Technology has changed, but s...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Neurological DeviceTalks West MedTech Medtronic Source Type: news

Endonovo Therapeutics finally buys Rio Grande Neuroscience assets for nearly $5m
Nearly a year-and-a-half after their planned $22 million merger fell through,Endonovo Therapeutics (OTC:ENDV) said last week that it acquired intellectual property and assets from Rio Grande Neurosciences for $4.5 million. Rio Grande in August 2016 backed out of deal with Endonovo after seeking to renegotiate its terms when Steven Gluckstern, chairman & CEO of Santa Fe-based Rio Grande, dissolved a binding letter of intent. Los Angeles-based Endonovo, which had raised $10 million to fund the $21.5 million buyout, was to have put up $1.5 million in cash, another $15 million in ENDV shares and $5 million worth ...
Source: Mass Device - December 27, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Wall Street Beat Source Type: news

Report: Apple is working on an in-house Apple Watch ECG to compete with AliveCor ’ s Kardiaband
Apple (NSDQ:AAPL) is reportedly developing an in-house ECG for its Apple Watch that would compete with the recently approved KardiaBand made by AliveCor. The Apple ECG, which is still being testing, involves smartwatch users squeezing the frame of the device with the opposite hand, allowing Apple Watch to pass an imperceptible current across the chest to assess heart rhythm, according to Bloomberg, which cited “people familiar with the plan.” Last month the FDA cleared AliveCor’s KardiaBand ECG device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in M...
Source: Mass Device - December 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular mHealth (Mobile Health) Wall Street Beat AliveCor Apple 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

Cerebrotech wins expanded CE Mark for brain bioimpedance monitor
Brain monitor dev Cerebrotech Medical Systems said today it won expanded CE Mark approval in the European Union for its portable brain bioimpedance monitor with indications for detecting bioimpedance asymmetry associated with stroke. The certification expands previously won clearance which indicated the device for use in detecting changes to intracranial fluid in patients at risk for edema, the Pleasanton, Calif.-based company said. “Our ability to quickly assess and respond to strokes is critical to ensuring good outcomes for our patients. Having access to a device that can give us this information rapidly has the p...
Source: Mass Device - November 29, 2017 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Neurological Regulatory/Compliance Cerebrotech Medical Systems Source Type: news

Qool Therapeutics raises $8m to support temp management device
Early stage med device developer Qool Therapeutics said today it raised $8 million in a Series A-1 round to support development and trials of its Qool device designed for targeted temperature management and exercise recovery. Joining the funding round was Zhongji Holdings and Join Medical Technology, Tampcap LLC, BrilliMedical International, BioPacific Investors, Western Technology Investment and FundRx, the Silicon Valley-based company said. Qool Therapeutics said that in addition to the funding, it has also received an award from the US Department of Defense’s Defense Innovation unit Experimental organization. The ...
Source: Mass Device - November 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Respiratory qooltherapeutics 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