Foldax announced today that the first 30 patients have been treated outside the U.S. with its Tria polymer surgical mitral heart valve. The procedures took place as part of the commencement of a clinical trial in India. Tria remains investigational and not available for commercial sale. Salt Lake City-based Foldax designed Tria to accommodate the […]
Replacement Heart Valves
Abbott is pulling its Trifecta valves off the market
Abbott announced today that it is withdrawing its Trifecta family of heart valves from worldwide markets. The market withdrawal comes more than five months after Abbott and the FDA told health providers that the valves could deteriorate early. In a statement shared with MassDevice, the company said: “Abbott has decided to withdraw and discontinue its […]
Anteris Technologies touts first successful implant of DurAVR THV in valve-in-valve procedure
Anteris Technologies announced today that surgeons used its DurAVR heart valve for the first time in a valve-in-valve (ViV) procedure. Brisbane, Australia-based Anteris — which has U.S. operations in Minneapolis — designed TurAVR THV as a new class of biomimetic heart valve. The company says it’s the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped […]
TAVR sales were up 9% for Edwards in Street-beating Q2
Edwards Lifesciences shares fell after hours today despite second-quarter results that beat the consensus forecast. Shares of EW dipped 6.3% to $85.85 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.6%. The Irvine, California-based company posted profits […]
Onecrea Medical completes first-in-human implants of TAVR system
Onecrea Medical recently announced that it successfully completed first-in-human implants for its transcatheter aortic valve replacement (TAVR) system. The company designed its next-generation TAVR system to treat aortic stenosis. With a unique concave and convex structure, the TAVR system anchors the valve effectively in the aortic annulus. This helps to avoid common complications with TAVR, […]
J&J’s Abiomed recalls Impella again — this time it’s TAVR-related
Johnson & Johnson’s Abiomed unit issued another recall for some of its Impella heart pumps. FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from […]
FDA clears Teleflex’s Wattson temporary pacing guidewire
Teleflex (NYSE:TFX) announced today that it received FDA clearance for its Wattson temporary pacing guidewire for use in heart procedures. Wayne, Pennsylvania-based Teleflex says it’s the first commercially available bipolar temporary pacing guidewire designed specifically for use during TAVR and BAV. The company plans to feature Wattson at TVT: The Structural Heart Summit, June 7-10 […]
Conformal Medical raises $35M in oversubscribed Series D
Conformal Medical today announced the successful completion of its Series D funding round, where it raised a total of $35 million. The oversubscribed Series D was led by Sprig Equity, with participation from all major Series C investors. “Sprig Equity is focused on enabling transformative medical technology companies to achieve meaningful milestones and, more importantly, […]
Medtronic reports positive Harmony transcatheter pulmonary valve data
Medtronic (NYSE:MDT) announced positive two-year results for a study of its Harmony transcatheter pulmonary valve (TPV) system. Harmony treats severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). The Medtronic analysis demonstrates strong clinical and hemodynamic outcomes for patients with a congenital heart defect of the RVOT. The current […]
Abbott reports positive data for TriClip TEER system
Abbott today announced late-breaking data supporting the benefits of its TriClip transcatheter edge-to-edge repair (TEER) system. The company presented study data at EuroPCR in Paris. This study evaluated TriClip, a first-of-its-kind, minimally invasive device, in treating patients with leaky tricuspid valves. Abbott’s bRIGHT study supported the safety and effectiveness of TriClip in 511 patients with […]
Study backs Edwards aortic valve with Resilia tissue
Edwards Lifesciences (NYSE:EW) today announced new data from a clinical trial evaluating bioprosthetic aortic valves with its Resilia tissue. Data from the COMMENCE aortic trial demonstrated low rates of structural valve deterioration (SVD) in the bioprosthetic valves. It represents the longest clinical follow-up for Edwards’ valve with Resliia tissue at a mean of 7.7 years. […]