Data from Edwards Lifesciences’ (EW) Cohort B of the PARTNER trial were published in The New England Journal of Medicine recently. The trial is targeted at those patients for whom conventional open-heart valve surgery is considered risky.
The company’s transcatheter heart valve (THV) portfolio has been developed to treat heart valve diseases using catheter-based approaches compared with open surgical techniques. Edwards’ 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. However, under Cohort A, patients were randomized for either high-risk surgery option or the Sapien THV.
It has been observed that for patients with Sapien THV, the death rate was significantly lower after a year compared to patients who were on standard therapy. However, a higher incidence of major stroke and vascular events occurred in patients who received Sapien. Edwards 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.
In October 2009, Edwards had submitted an Investigational Device Exemption (IDE) for clinical trial (PARTNER II) of Sapien XT. Recently, the US Food and Drug Administration (FDA) have conditionally approved the first of two planned cohorts of the trial which will study the Sapien XT THV with the low-profile NovaFlex transfemoral delivery system. The study, to be conducted with 450 patients, will be randomized two-to-one to receive either the Sapien XT or standard therapy. While the primary endpoint will include death, major stroke and repeat hospitalization, valve performance and quality of life are the secondary endpoints.
In addition, during the second quarter of 2010, Edwards began enrolling patients in a trial with its Sapien XT valve, called PREVAIL JAPAN. Enrollment is progressing well and the company is on track to get the device approved in 2013.
Both Sapien and Sapien XT are approved in Europe. Although Edwards has witnessed strong growth for its THVs banking upon the successful launch of Sapien products in Europe, the product has yet to receive approval in the U.S. or Japan. Approval of the device in these two countries should boost the company’s revenues in the long term.
We have a Neutral rating on the stock.
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