California-based medical device maker Direct Flow Medical touted European regulatory approval for its transcatheter aortic valve implantation system, which the company says "virtually eliminates aortic regurgitation."
The device touts a metal-free frame and a low-profile delivery system, as well as a double-ring design that is both repositionable and retrievable after full deployment.
European healthcare officials cleared 2 sizes of the Direct Flow valve and both will be on the market immediately, according to a press release.
Direct Flow recently unveiled 30-day clinical trial results for its TAVI system, reporting that 95% of its enrolled patients experienced mild or less aortic regurgitation.
Valve leakage, which can lead to aortic regurgitation, is one of the chief challenges with 1st-generation TAVI systems and one that many next-generation devices are looking to address.
Medtech giant Medtronic (NYSE:MDT) in October 2012 reported early results from the pivotal CE Mark trial of its Engager TAVI system, touting reduced valve leakage and easier device deployment. Similar reports came from an early feasibility study of Boston Scientific’s (NYSE:BSX) Lotus transcatheter aortic valve implantation, which also showed precise positioning on the 1st attempt and almost compete obliteration of aortic regurgitation, according to investigators.
Direct Flow hopes to hold its own against its larger rivals with its TAVI system, which features an inflatable cuff and polymer support structure.