Medtronic Inc. (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) both got the thumbs up for their heart valves from regulatory bodies, but Edwards is ahead of Medtronic in bringing a device to the U.S. market with FDA approval to expand clinical trials of its Sapien system.
The federal watchdog agency conditionally approved a second treatment group to an ongoing trial of Irvine, Calif.-based Edwards’ transcatheter heart valve trials. They hope to complete enrollment in the trial by the end of the calendar year, according to a press release.
Edwards broke the tape in the race to get a TAVI device to the U.S. market last week, after the FDA granted its pre-market approval application last week. The Sapien system valve is also on the market in Europe, where it received a CE Mark in March 2010.
Med-tech goliath Medtronic’s CoreValve system has also been cleared for the European market. Today the company announced approval for an additional indication, with CE Mark approval for use in patients with severe heart disease who are at high risk or unable to undergo open-heart surgery.
Medtronic’s system is designed as a minimally-invasive approach to replace diseased aortic valves without open-heart surgery.
Edwards and Medtronic have gone back and forth in valve patent disputes, most recently resulting in a $74 million patent infringement loss for Medtronic. A federal judge denied Edwards’ move to bar U.S. manufacturing and sales of CoreValve, which Medtronic acquired in in its $700 million buyout of CoreValve Inc. in 2009.
Medtronic also announced a novel approach to minimally invasive spinal fusion allowing surgeons to access the spine in the lower back, according to a press release.