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.

 
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