Medtronic Receives FDA Approval for Testing Artificial Heart Valve
Posted Oct 18 2010 12:11am
Back in 2008 this was a breakthrough and only a couple years later 12,000 patients overseas have had this procedure done.
This is an interventional procedure so an answer for seniors who may not be able to tolerate full open heart surgery. BD
Medtronic Inc., the world's largest medical device maker, said Friday it received U.S. regulatory approval to begin testing a new artificial heart valve that can be implanted with minimal surgery.
The company said the Food and Drug Administration gave clearance to study the company's CoreValve system in the U.S. The product has already been implanted in 12,000 patients abroad.
The CoreValve implant is designed to be snaked through a major artery and fitted into place without the open-heart surgery typically required for implanting a new heart valve. The product is seen as an important option for patients too old or frail to undergo open-heart surgery.
Competitor Edwards Lifesciences pioneered the technology and is on target to gain FDA approval for its Sapien valve late next year.