Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its TYRX absorbable antibacterial driveline wrap. Fridley, Minn.-based Medtronic’s TYRX system is designed to securely hold a percutaneous driveline for patients receiving a ventricular assist device (VAD), according to a news release. Drivelines connect the implanted heart pump to an external controller powered by […]
Abbott gains CE Mark for next-gen MitraClip
Abbott (NYSE:ABT) announced today that it received CE Mark approval in Europe for its fourth-generation MitraClip system. MitraClip G4, the latest installment of the Abbot Park, Ill.-based company’s transcatheter mitral valve repair (TMVR) system, is now approved for use in countries recognizing the CE Mark as a non-surgical option for treating mitral regurgitation (MR) or a […]
Medtronic touts savings of using antibacterial ‘envelope’
Medtronic (NYSE:MDT) is touting new data from its WRAP-IT study demonstrating the cost-effectiveness of its TYRX absorbable antibacterial envelope. Fridley, Minn.-based Medtronic designed its TYRX absorbable antibacterial envelope for patients at increased risk of infections who receive cardiac implantable electronic devices (CIEDs). Results from the WRAP-It study, published in Circulation: Arrhythmia and Electrophysiology, showcase the cost-effectiveness […]
Advisory panel to vote on FDA approval of Neovasc Reducer
Nine years after it won the CE Mark in Europe, the Neovasc (NSDQ:NVCN) Reducer device, designed to treat refractory angina, is close to an FDA decision on premarket approval. The agency’s Circulatory Systems Devices Panel is scheduled to discuss the Reducer at a virtual meeting set for Oct. 27, the FDA announced today. In a […]
7 technologies to make a ‘new Medtronic’ even more powerful
It’s been four months since Geoff Martha took over the corner office at Medtronic (NYSE:MDT), and it’s becoming clear that he has ambitious plans for the world’s largest medical device company. During the company’s Q1 earnings call on Aug. 25, Martha said management in the coming weeks plans to outline plans for a “new Medtronic” that […]
CMS proposes coverage updates that could increase access to VADs
The Centers for Medicare & Medicaid Services (CMS) today proposed coverage policy updates meant to increase access to VADs and artificial hearts. The policy updates, if approved, could be good news for major VAD makers Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) — as well as people with heart failure who are waiting for a heart transplant or don’t […]
Neovasc raises $12.6M
Neovasc (NSDQ:NVCN) announced today that it agreed to sell shares of its common stock in a registered direct offering worth approximately $12.6 million. Vancouver, Canada-based Neovasc entered into definitive agreements with “certain healthcare-focused institutional investors,” according to a news release, for the offering that is expected to close on Aug. 12, according to a news release. […]
Conformal Medical raises $70 million
Stroke prevention technology developer Conformal Medical filed an SEC Form D to confirm the sale of $70 million in an equity offering. Nashua, N.H.-based Conformal Medical is offering $85 million in equity in total, leaving $15 million left to be sold. It made the first sale in the new notice offering on July 24 and […]
FDA issues EUA for Abiomed Impella heart pumps for COVID-19 therapy
Abiomed (NSDQ:ABMD) announced today that the FDA issued emergency use authorization (EUA) for its Impella heart pumps in COVID-19 therapy. The EUA covers the left-sided Impella pumps in providing left ventricular unloading, supporting COVID-19 patients who are undergoing extracorporeal membrane oxygenation (ECMO) treatment and develop pulmonary edema or myocarditis, according to a news release. Impella, the […]
The 18 most innovative medical devices of 2020
The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien process, we are honored […]
Boston Scientific’s next-gen stroke prevention device gets FDA nod
The FDA has approved the next-generation of Boston Scientific’s (NYSE:BSX) Watchman left atrial appendage closure (LAAC) device, the company announced today. The Marlborough, Mass.-based company describes the Watchman FLX as a permanent implant designed to close off the left atrial appendage and thus reduce the risk of stroke without the bleeding danger associated with blood-thinners. It […]
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