Edwards Lifesciences Corporation (EW), one of the leading players in heart valves and hemodynamic monitoring, is expected to announce results from the PARTNER trial cohort B at the upcoming Transcatheter Cardiovascular Therapeutics on September 23. Heart valve therapy accounted for 59% of total revenue in the second quarter of fiscal 2010. Contribution from this segment has increased steadily over the past, from 47% in 2007 to 54% in 2009.
Edwards has developed transcatheter heart valve (THV) replacement and repair technologies, aimed 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 Sapien XT.
In March 2007, Edwards received conditional Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate PARTNER trial related to Sapien THV technology. The trial is targeted at those patients for whom conventional open-heart valve surgery is considered risky.
Patients have been randomized equally for either high risk surgery option or the Sapien THV in the first study arm (cohort A). Following a similar pattern, patients (considered unfit for surgery) in the second study (cohort B) were randomized equally for medical management option or the Sapien THV. Provided results are encouraging, 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 IDE for clinical trial (PARTNER II) of Sapien XT. However, this trial has hit a roadblock with some questions being posed by the FDA. The company is in discussions with the agency and expects to receive IDE approval in the third quarter of 2010.
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.
Although Edwards has witnessed strong growth for its THVs banking upon the successful launch of Sapien products in Europe, the product is yet to receive approval in the US. Although the company has not commented on the data for PARTNER trial, favorable data comparison along with one-year approval process could result in the US approval of Sapien THV for medically managed patients in 2011. Approval of the device in the US or Japan should boost the company’s revenues in the long term.
We have a Neutral rating on the stock, which also corresponds to a Zacks #3 Rank (short term hold recommendation).
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