Recently, Edwards Lifesciences Corporation (EW - Free Report) disclosed preliminary results from The Partner II Trial at the 62nd Annual Scientific Session of American College of Cardiology (ACC) in San Francisco. The clinical trial evaluated the performance of transcatheter aortic valve replacement (TAVR) in inoperable patients with acute, symptomatic aortic stenosis. It was carried out from Apr 2011 to Feb 2012. We are encouraged to see Edwards’ progress with The Partner II Trial in a timely manner as the one-year data from the clinical study was expected in early March.
The Partner II Trial was conducted in 28 hospitals across the U.S. on 560 inoperable patients for the conventional open-heart procedure. The patients were randomly selected to receive either of the two transcatheter aortic valves. As a result, 284 patients received the Sapien XT valve and 276 patients received the Sapien valve.
The outcome of the clinical trial displayed similarity on mortality and crucial clinical events between the company’s Sapien XT transcatheter aortic valve and Sapien valve. According to the data, the probability of strokes and death in patients with either of the valves is pretty close. Nonetheless, the patients with Sapien XT valve recorded lesser vascular events. Outcomes from the inoperable cohort (Cohort B) trial demonstrate the clinical competency of the Sapien XT valve.
While the Sapien valve won the approval from the U.S. Food and Drug Administration (FDA) in Nov 2011 for inoperable patients, the highly anticipated approval for the indication of high-risk surgical patients came in Oct 2012. On the other hand, Edwards’ Sapien XT is yet to be launched in the U.S. The company plans to submit Cohort B clinical results from The Partner II Trial for the FDA approval in the second quarter of 2013. In the interim, Edwards anticipates to round off enrollment in the intermediate risk cohort (Cohort A) of The Partner II Trial by mid-2013.
Based on these facts, the approval of Sapien XT is anticipated in 2014 in the U.S. Also worth mentioning is that Edwards is in the process of collecting follow up data from the clinical trials on Sapien XT valve in Japan and the regulatory approval is expected later this year. We are encouraged to note that the company is also working on approval for Sapien XT in China by 2013.
We believe that the transcatheter aortic valves offer the most promising opportunity in the cardiac device space for Edwards. We also believe that the transcatheter heart valve (THV) segment of the company has the potential to lead sales and earnings over the long haul.
The stock carries a Zacks Rank #2 (Buy). Other Zacks Rank #2 medical stocks are CareFusion , Conceptus and Covidien .