A follow-up of surgical and medical treatment for congestive heart failure and coronary artery disease (STICH) showed that there’s no association between myocardial viability and the long-term mortality benefit of coronary artery bypass grafting (CABG) in patients with ischemic cardiomyopathy. The study, published yesterday in the New England Journal of Medicine, followed 601 patients with coronary […]
Niowave raises $3m in equity funding
Niowave raised $3 million in equity funding, company CFO Mike Zamiara confirmed after the company filed an SEC Form D this week. Zamiara told MassDevice.com via email that the funding “allows us to continue to develop our medical isotope program,” while it also will help the company meet its match requirement for a grant from […]
These 5 DIY medical devices might surprise you
Big ideas in medical device development can come from regular people driven to solve vexing problems. Here are a handful of folks from outside the medtech industry who decided to create devices to solve their own health troubles or those of others around the world. Read on to see what high school, college and medical […]
FDA grants breakthrough nod to Miracor Medical’s PiCSO device
Miracor Medical said today that it received breakthrough designation from the FDA for its PiCSO device for treating a type of heart attack. The PiCSO (pressure-controlled intermittent coronary sinus occlusion) system is designed to clear coronary microcirculation by intermittently stopping the delivery of blood through the coronary sinus into the right atrium. The intended result […]
Study: No difference between Biotronik, Medtronic or Boston Scientific stents
A study comparing drug-eluting stents made by Biotronik, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) found no statistically significant difference on target vessel failure or stent thrombosis after three years. The 3,514-patient Bio-Resort trial compared Biotronik’s Orsiro biodegradable sirolimus-eluting stent, Medtronic’s thin-strut zotarolimus-eluting Resolute Integrity stent and the Synergy biodegradable everolimus-eluting stent. Get the full story at […]
AliveCor stops selling KardiaBand ECG for Apple Watch
AliveCor reportedly yesterday said that it ended sales of its KardiaBand for use with the Apple Watch. The company stopped selling the device in June and has pulled the device from its Amazon vendor profile as well, according to MobiHealthNews. “In 2017, we were proud to launch the first FDA-cleared accessory for the Apple Watch,” […]
FDA OKs Adagio Medical’s cryoablation afib trial
Adagio Medical yesterday said it received an investigational device exemption from the FDA for a clinical trial of its cryoablation device for treating atrial fibrillation. The 80-patient study, a non-randomized, single-arm trial of subjects with persistent afib, will use the Laguna Hills, Calif.-based company’s intelligent continuous lesion ablation system to treat patients with afib of […]
Philips announces European launch of HeartStart Intrepid defib
Royal Philips (NYSE:PHG) today announced that it launched its HeartStart Intrepid monitor/defibrillator with IntelliSpace Connect in Europe and other worldwide markets. HeartStart Intrepid allows caregivers to evaluate and treat patients in demanding medical emergencies. The device is available in Europe and select markets in Asia and Africa. “First responders don’t often know what to expect when […]
Study shows few amputations following treatment with Cardiovascular Systems’ PAD system
A study of peripheral vascular interventions in patients with peripheral artery disease (PAD) has demonstrated “high freedom” from major amputation at three years, according to study sponsor Cardiovascular Systems. The Liberty 360° study enrolled more than 1,200 patients at 51 sites across the U.S. It followed patients across the spectrum of symptomatic PAD, and included […]
CVRx’s Barostim Neo system earns FDA approval
CVRx said today it won FDA approval for its Barostim Neo system, the world’s first heart failure neuromodulation device. The Minneapolis-based company’s device is designed to improve symptoms in patients with advanced heart failure who are not suited for other heart failure devices by electrically activating the baroreflex to reduce sympathetic activity and increase parasympathetic […]
Abbott’s MitraClip may win expanded Medicare coverage
Abbott’s (NYSE:ABT) MitraClip heart valve device may secure Medicare coverage for an additional procedure. The Center for Medicare and Medicaid Services (CMS) announced yesterday that it will study whether to extend coverage of the MitraClip transcatheter mitral valve repair (TMVR) device in cases of secondary mitral regurgitation, which results from left ventricular dysfunction. Medicare already pays […]
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