Edwards Lifesciences Corporation (EW) received a favorable recommendation from the advisory panel of the US Food and Drug Administration (FDA) for its Sapien transcatheter heart valve (THV).
This approval comes for the treatment of patients with severe aortic stenosis and those deemed unfit for conventional open-heart valve surgery.
The company had submitted a pre-market approval (PMA) application in October 2010 for Cohort B of the PARTNER trial. Under Cohort B, patients with severe aortic stenosis and those considered unfit for surgery were randomized for standard therapy or the Sapien THV (delivered transfemorally). Results from this study carried out on over 358 patients, were published in The New England Journal of Medicine in September 2010.
Although the panel voted in favor (9-0 with one abstention) of the device, they are concerned about higher rates of developing neurological problems, particularly stroke in patients treated with Sapien. With respect to effectiveness (9-1) and safety (7-3), the panel upheld Sapien.
The guidance provided by Edwards for 2011 assumes $20-$25 million of THV sales in the US. Following favorable recommendation from the FDA panel, the probability of approval in the US has improved. Although Sapien is approved in Europe, approval in the US or Japan should boost revenues of the company in the long term. Leading medical devices player, Medtronic (MDT) is also developing CoreValve in the US (already approved in Europe) targeting this patient population.
During the first quarter of fiscal 2011, Heart Valve Therapy recorded an annualized growth of 24.5% to $244.9 million. Sales of surgical heart valves grew 9.2% to $172.2 million and THV recorded an 85.7% growth to reach $72.7 million.
We currently have a Neutral recommendation on Edwards which is also supported by the Zacks #3 Rank (Hold).
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