Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]
Medtronic appoints new VP & CMO for coronary, renal denervation & structural heart
Medtronic (NYSE:MDT) announced that it appointed Dr. Jeffrey Popma as its new VP and chief medical officer for coronary, renal denervation and structural heart business. Popma, a professor of medicine at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston, is slated to provide medical leadership across those businesses, […]
Alleviant Medical completes $6.5m offering
Congestive heart failure treatment developer Alleviant Medical filed an SEC Form D to confirm the sale of $6.5 million in an equity offering. The Austin, Texas-based company reached its total offering amount of $6.5 million after making the first sale in the new notice on May 1. It had no intention of letting the offering […]
Edwards lands CE Mark for Pascal transcatheter valve repair system to treat TR
Edwards Lifesciences (NYSE:EW) announced today that it received CE Mark approval for its Pascal transcatheter valve repair system for treating tricuspid regurgitation (TR). Pascal won its indication in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. The device uses clasps and paddles to grasp the leaflets and facilitate coaptation, […]
Medtronic touts positive results for Melody TPV, Harmony TPV
Medtronic (NYSE:MDT) today announced the results of two successful clinical trials for its Melody transcatheter pulmonary valve (TPV) therapy. The Fridley, Minn.-based medtech giant virtually presented its 10-year outcomes at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) scientific sessions. Melody demonstrated strong long-term hemodynamic and safety outcomes, while the investigational Harmony TPV pivotal trial […]
Zoll Medical wins CE Mark for oxygen therapy system
Zoll Medical announced today that it received CE Mark approval in Europe for its TherOx SuperSaturated Oxygen (SSO2) therapy system. SSO2 therapy offers interventional cardiologists a treatment beyond percutaneous coronary intervention (PCI) that significantly reduces muscle damage in heart attack patients. Chelmsford, Mass.-based Zoll’s therapy system delivers hyperbaric levels of oxygen directly to damaged heart […]
These medical devices are getting ready to launch in 2020
Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year. The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs beginning Feb. 4 and had approved […]
AtaCor Medical completes $25m Series B
Extracardiac temporary pacing technology developer AtaCor Medical announced today that it completed a $25 million Series B financing round. Existing investors Broadview Ventures and aMoon Fund led San Clemente, Calif.-based AtaCor’s funding round, while new investors Hatteras Venture Partners, Catalyst Health Ventures and Longview Ventures contributed. Hatteras partner Jeff Terrell and Catalyst Health Ventures managing […]
Edwards Lifesciences beats The Street on Q1 results, expects a tough Q2
Edwards Lifesciences (NYSE:EW) posted first-quarter results this evening that beat The Street but cut its outlook for the rest of the year as health providers and patients grapple with the COVID-19 pandemic. The Irvine, Calif.–based structural heart disease and critical care monitoring company reported profits of $310.6 million, or $1.47 per share, on sales of $1.1 […]
Teleflex warns on Pilling Clear Advantage aortic punch
The United Kingdom today issued a safety notice to warn on the Pilling Clear Advantage aortic punch manufactured by Teleflex (NYSE:TFX). Teleflex recalled the Pilling Clear Advantage aortic punch in January after discovering the potential for compromised device packaging. If the packaging is compromised, the sterility of the device can’t be guaranteed, meaning use could result […]
Medtronic field safety notice in Europe involves potentially serious HVAD problem
Medtronic (NYSE:MDT) issued a field safety notice in Europe to warn on potential damage occurring during pre-implant procedures with its HeartWare HVAD system. The Fridley, Minn.-based company’s HVAD heart pump has an outflow graft that may be subject to tears, and its strain relief screw may break during the pre-implant pump assembly and attachment to the […]
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