HighLife (Paris) recently announced it raised €80 million (more than $90 million U.S.) for a U.S. pivotal study and expanded European commercialization of its TMVR system. The successfully completed fundraise, announced Sept. 22, was co-led by Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners. Other new investors … [Read more...] about HighLife raises more than $90M to advance its TMVR system
Heart valves
Edwards Lifesciences, Medtronic score CMS win over TAVR
Edwards Lifesciences (NYSE: EW) and Medtronic (NYSE: MDT) are among the medtech companies praising CMS’s decision to expand Medicare coverage for TAVR to people with asymptomatic severe aortic stenosis. The finalized national coverage decision, published yesterday evening, also removes the evidence development (CED) requirement for symptomatic … [Read more...] about Edwards Lifesciences, Medtronic score CMS win over TAVR
enVVeno Medical wins FDA IDE for non-surgical transcatheter replacement venous valve
enVVeno Medical (Nasdaq:NVNO) announced today that it received FDA investigational device exemption (IDE) for its enVVe system. The IDE allows Irvine, California–based enVVeno (formerly Hancock Jaffe) to begin the TAVVE pivotal trial for the system. It represents a first-in-class minimally invasive, non-surgical replacement venous valve for … [Read more...] about enVVeno Medical wins FDA IDE for non-surgical transcatheter replacement venous valve
Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Medtronic (NYSE:MDT) has issued a letter to affected customers recommending the removal of certain lots of its Harmony delivery catheter system (DCS). In a notice published by the FDA, the agency said Medtronic's recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type, as it could … [Read more...] about Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Protaryx earns FDA nod for transseptal puncture device
Protaryx Medical announced that it received FDA 510(k) clearance for its proprietary Transseptal Puncture Device. Baltimore-based Protaryx said clearance marks a significant advancement in its mission to redefine safe, efficient and reproducible left heart access. for cardiac interventions. It hopes to enable broader adoption and improved … [Read more...] about Protaryx earns FDA nod for transseptal puncture device
Peijia Medical seeks CE mark for its TEER system
Peijia Medical (Suzhou, China) announced today that it has submitted to receive a CE mark for its GeminiOne transcatheter edge-to-edge repair (TEER) system to treat mitral regurgitation. Paris-based HighLife, which recently secured a CE mark for its transcatheter mitral valve replacement (TMVR) system, is Peijia Medical's European partner in the … [Read more...] about Peijia Medical seeks CE mark for its TEER system
Medtronic to invest up to $90M in Anteris Technologies
Anteris Technologies (Nasdaq: AVR, ASX: AVR) says medtech giant Medtronic (NYSE: MDT) will make a strategic investment of up to $90 million in the transcatheter heart valve developer. The private placement, announced after market close yesterday, requires Medtronic to acquire a 16.0–19.99% stake in Anteris. In addition, Anteris is proposing a … [Read more...] about Medtronic to invest up to $90M in Anteris Technologies
Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
Edwards Lifesciences [WtwhTicker symbol="EW"](NYSE: EW)[/WtwhTicker] has won FDA approval for its Sapien M3 mitral valve replacement system for treating mitral regurgitation (MR). The company said it's the first approval for a transcatheter MR therapy utilizing a transseptal approach. The approval came earlier than Edwards expected. The … [Read more...] about Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
12 things you need to know about the transcatheter heart valves market
Transcatheter heart valve repair and replacement have reshaped how structural heart disease is treated, and the market behind these technologies is evolving just as quickly. As valve design improves, delivery systems become more refined, and patient eligibility expands, transcatheter therapies are moving from niche alternatives to standard of … [Read more...] about 12 things you need to know about the transcatheter heart valves market
Transcatheter heart valves market to enjoy solid growth
The global, multibillion-dollar transcatheter heart valves market will grow at an 8.4% CAGR over the rest of the decade, according to MassDevice's latest Medtech Market Intelligence Report. Minimally invasive therapies have gained traction in the management of structural heart disease, and the field continues to evolve. The most established … [Read more...] about Transcatheter heart valves market to enjoy solid growth
