Recently, Edwards Lifesciences (EW) presented encouraging data from its PARTNER trial (Cohort B) at the American Heart Association in Chicago. The trial is targeted at those patients for whom conventional open-heart valve surgery is considered risky.

In September, the company had presented key data on mortality rates from this study. Recent data shows that the same patient population experienced a better quality of life on being treated with Edwards’ Sapien transcatheter heart valve (THV).

Edwards’ THV portfolio has been developed to treat heart valve diseases using catheter-based approaches compared with open surgical techniques. The company’s product portfolio for valve replacements consists of Sapien THV and the next-generation Sapien XT.

The Cohort B was conducted with 358 patients who were not considered fit to undergo traditional open-heart surgery. Patients were randomized to receive either the Sapien THV or standard therapy. These patients were assessed after intervals of one month, six months and twelve months on various parameters such as symptoms, physical and social limitation or the quality of life.

Edwards is also studying the Sapien valve in another group of patients, Cohort A. Here, patients were randomized for either high-risk surgery option or the Sapien THV.

Although the Sapien portfolio of valves in approved in the US, it is yet to receive approval in the US. The company anticipates submitting a pre-market approval (PMA) application for Cohort B to the FDA in the fourth quarter of 2010 and Cohort A in mid−2011. The heart valve space is likely to become more competitive with Medtronic (MDT) receiving conditional approval in October from the US Food and Drug Administration for studying its CoreValve system.

Edwards has witnessed strong growth for its THVs banking upon the successful launch of Sapien products in Europe. During the third quarter, Heart Valve Therapy remained the strongest segment at Edwards with an annualized growth of 15.2% to $200.6 million. Sales of surgical heart valves grew 3.4% (on adjusted basis), while THV sales recorded an 85% growth to reach $48.8 million. Edwards expects to record $190-$205 million of sales from THVs in 2010.

We are currently Neutral on Edwards.

 
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