FDA Approves Expanded Use for Heart Valve
Published date : 23 October 2012
Article date : 23 October 2012
The Los Angeles Times reports that Edwards Lifesciences has gained FDA clearance to expand use of the company's transcatheter heart valve, as an alternative to open-heart surgery.
They say that the device is meant to treat severe aortic stenosis and that the device label states that the opinion of a heart surgeon should be taken into account when considering whether Sapien is the right choice for the patient.
Device manufacturer, Medtronic, is now testing a similar device, CoreValve, and the company expects to receive FDA approval in 2014 for porocedures where patients unsuitable for surgery.
Source: Los Angeles Times, 23 October 2012
Read the original article here.