Mitral ring finally gets 510(k)
This article was originally published in The Gray Sheet
Executive Summary
Specialized mitral valve repair device removed from the market last October by Edwards Lifesciences is reintroduced following 510(k) clearance April 10. Now known as the dETlogix 5100 annuloplasty ring, the device was previously called Myxo ETlogix. Edwards submitted the 510(k) in October following charges that the device was being marketed without proper regulatory clearance and implanted without proper disclosure to patients (1"The Gray Sheet" Dec. 8, 2008, p. 5). An FDA spokeswoman says the agency ultimately determined that Edwards should have sought a 510(k) before the initial 2006 launch. But FDA has decided not to sanction the firm because it appears Edwards made an honest attempt to follow agency guidance, she said. The ring was designed primarily to treat myxomatous disease, a degenerative mitral valve condition, though the new clearance does not specify that indication