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 […]
Stroke
Russian study pits InspireMD’s CGuard device against Abbott’s Rx Acculink carotid stent
InspireMD (NYSE:NSPR) this week touted an independent clinical trial in Russia pitting its CGuard embolic protection device against the Rx Acculink carotid stent made by Abbott (NYSE:ABT). The 100-patient trial is designed to compare the two devices in terms of neuroprotection and clinical superiority in subjects undergoing carotid endarterectomy, the Tel Aviv-based company said. Conducted at the Scientific Research […]
Artificial intelligence accurately predicts stroke risk
Machine-learning algorithms, a form of artificial intelligence, accurately predicted people’s risk of heart disease and stroke, according to new research from the University of Nottingham. Researchers and computer scientists compared the risk guidelines for heart disease and stroke from the American College of Cardiology with 4 machine-learning algorithms to analyze the risk of a patient […]
Slow enrollment delays Nexstim pivotal trial
Nexstim said today that slow enrollment in pivotal trial of its Navigated Brain Therapy transcranial magnetic stimulation device in treating patients rehabilitating from stroke. The 60-patient E-Fit study, launched in March, is designed to supplement Nexstim’s already complete Niche study. The Finnish company originally expected to conclude the E-Fit supplemental during the 1st quarter next year, but said […]
Penumbra prices $99m offering
Penumbra (NYSE:PEN) said today that it priced a public offering worth nearly $99 million, not including an underwriter’s option worth nearly $15 million. Alameda, Calif.-based Penumbra makes a line of instruments designed for neurovascular and peripheral vascular procedures, including stroke revascularization, embolization and thrombectomy. The company said it plans to float 1.3 million shares at $76 […]
Stryker halts enrollment early in Trevo study on high probability of success
Stryker (NYSE:SYK) said today that it’s putting an early stop to enrollment in a clinical trial of its Trevo anti-stroke device after a review board decided there’s a high probability of success for the study. Kalamazoo, Mich.-based Stryker paid $135 million for Concentric Medical and its Trevo clot retriever back in 2011. The device is […]
7 wearable medtech companies to see at the Wearable Technology Show
Wearable devices aren’t going anywhere anytime soon in the world of medtech. The Wearable Technology Show 2017 is taking place March 7 and March 8 at the Excel in London, offering a chance to check out some of the latest wearable devices. Digital health technology, smart textiles and sensors, and augmented reality are just some of the […]
FDA expands indication for Medtronic’s Solitaire stent retriever
Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for an expanded indication for its Solitaire stent retriever. The new indication covers its use as an initial treatment for acute ischemic stroke after the administration of intravenous tissue plasminogen activator and within six hours of symptom onset, Fridley, Minn.-based Medtronic said. The Solitaire device is […]
Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements. The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead […]
Keystone Heart touts TriGuard cerebral protection data in TAVR patients
Keystone Heart today released data from transcatheter aortic valve replacement patients treated with its TriGuard cerebral embolic protection device, touting a significant reduction in brain lesions. TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR procedures, by allowing blood to pass […]
Boston Scientific halts EU sales of next-gen Watchman FLX anti-stroke device
Boston Scientific (NYSE:BSX) reportedly halted European sales of its the next generation of its anti-stroke device, the Watchman FLX, after receiving reports of device embolization. Spokeswoman Trish Backes told TCTMD that there were 6 device embolizations in 207 (2.9%) European implantations of the Watchman FLX, an implant that designed to occlude the heart’s left atrial […]
