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FDA Approves Edwards Lifesciences' Intuity Elite Heart Valve

Renowned heart valve manufacturer Edwards Lifesciences Corp EW recently got the FDA approval for its next-generation pericardial heart valve – the Intuity Elite System, two years after securing a CE Mark for this device. Subsequently, the company has commercially launched this rapid deployment device in the U.S. market.

In last few decades, coronary artery disease has become a very common medical condition affecting millions worldwide, with a rapid increase observed in patients suffering from aortic stenosis. In fact, in the U.S., heart disease has become the leading cause of death for both men and women. Aortic valve replacement is a standard procedure followed to treat such patients, typically involving an open-heart surgery.

With the advancement of medical technology, a minimally-invasive surgery for such a valve replacement is in vogue now a days, as it involves less complications associated with the procedure. Edwards’ Intuity Elite Valve system is one such valve that facilitates minimally invasive...


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