Edwards Lifesciences (NYSE:EW) is scheduled to speak at the Morgan Stanley Global Healthcare Conference in New York on September 13, 2011. The company’s CEO, Michael A. Mussallem, will talk about the company at the conference.
Investor focus is currently on Edwards as its Sapien transcatheter heart valve (THV) is under review by the US Food and Drug Administration. The company expects to receive approval for Cohort B (inoperable patients) by October 2011. Earlier, in July 2011, Edwards had received favorable recommendation from the FDA advisory panel for Sapien THV.
This endorsement will help the treatment of patients with severe aortic stenosis and those deemed unfit for conventional open-heart valve surgery (Cohort B). Although the panel voted in favor (9-0 with one abstention) of the device, they are concerned about vulnerability to neurological problems, particularly stroke in patients treated with Sapien.
With respect to effectiveness (9-1) and safety (7-3), the panel upheld Sapien. The launch, anticipated in the fourth quarter is expected to result in $20-$25 million of sales during the first quarter and $150-$250 million in the first full year.
However, the number of targeted centers in US in the first year was reduced to 150-200 (apart from the 25 clinical trial sites) from the previous guidance of 200-400. This change was made to fulfill FDA’s recommendation of more patients being treated in each center so that the rollout is tracked properly. Edwards is also working to secure reimbursement for the product.
The development of Sapien products holds immense potential for Edwards as it provides surgeons the option to eliminate the possibility of open heart procedures. Continued adoption of the new 29 mm Sapien XT valve in Europe led to a 60% rise in THV sales to $85.3 million during the quarter.
Based on robust performance so far, Edwards has raised its THV sales guidance for 2011. However, the company operates in a highly competitive environment in the midst of players such as Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX). Besides, any hiccup in the approval process of Sapien would be a major setback for the company.
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