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FDA Approves Edwards Lifesciences' Intuity Elite Heart Valve

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Renowned heart valve manufacturer Edwards Lifesciences Corp (EW - Free Report) 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 aortic valve replacement in patients suffering from heart disease.

Notably, as per the one year results from the company’s Transform Clinical trial, patients implanted with Edwards’ Intuity Elite valves have exhibited procedural benefits like decreased mortality and morbidity, less time in an intensive care unit as well as reduced total hospital stay. In fact it is these trial outcomes, which successfully demonstrated the safety and efficacy of Edwards’ Intuity Elite system and in turn, encouraged FDA to offer marketing approval for this device.

Post its launch in the European nations, a strong demand growth has been observed for the Intuity Elite valve system in the past two years. This demand buoys optimism about the system generating higher revenues for Edwards in the international market as well.  Evidently in the last reported second quarter results, Intuity Elite drove strong sales growth for Edwards in Europe.

We expect the company to observe similar sales growth in the U.S., on account of the recent launch of the Intuity Elite system. Management also anticipates a meaningful contribution to Edwards’ overall sales growth in 2016, from the Intuity Elite launch in the U.S.

With the global prosthetic heart valve market expected to reach a value worth $4.8 billion by 2020, we are optimistic about Edwards to capture larger shares in this market space on the back of its Intuity Elite system’ recent launch in the U.S. as well as persistently solid adoption of the company’s other valves globally.

Edwards currently holds a Zacks Rank #2 (Buy). Some better-ranked medical stocks worth mentioning are ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Anika Therapeutics Inc. (ANIK - Free Report) and Heska Corp. (HSKA - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).

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