Edwards' Sapien XT Betters Medtronic Heart Valve - Analyst Blog

A small study showed that Edwards Lifesciences Corp.'s EW next-generation Sapien XT replacement heart valve is superior to the CoreValve device developed by Medtronic, Inc. MDT, in terms of overall device success. Edwards recently presented a head-to-head comparison of Sapien XT with CoreValve at the American College of Cardiology's annual conference in Washington.

Edwards' shares gained 6.3% in the trading session following this impressive news release. The stock is up around 14% year-to-date.

The Choice Trial – in which Sapien XT outperformed CoreValve – was an investigation-initiated trial involving CoreValve and Sapien XT and was conducted on 241 patients with severe aortic stenosis in 5 medical centers in Germany. Each of these patients was randomly administered one of the 2 transcatheter aortic valve implants.

 The study revealed that 95.9% of the patients implanted with the balloon-expandable Sapien XT device achieved device success compared to 77.5% of patients confirming the same for the self-expandable CoreValve arm.

The primary endpoint of the trial was device success, which was defined as “successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location”.

Among the secondary endpoints, no significant difference was found between the two valves with respect to cardiovascular mortality, bleeding and vascular complications, post-procedural pacemaker placement, and a combined safety endpoint at 30 days including all-cause mortality, major stroke or other serious complications.

Sapien XT's significantly lower frequency of residual more-than-mild aortic regurgitation has enabled its success over CoreValve. Moreover, the study validated that a heart patient with a valve from Edward's Sapien group needs replacement at lesser frequent intervals vis-à-vis CoreValve.

At the conference, the authors declared that the study was limited by the use of angiography, instead of echocardiography, during the valve implantation. Since the CoreValve device expands even after implantation, it might have skewed the regurgitation results against it. For obtaining elaborate differences between the two devices, a more detailed study is necessary, as per the authors.

In the short term, it is true that improvement of heart failure symptoms is more frequent in patients with a Sapien XT valve. However, in the long run, whether Sapien XT will be able to translate its device success into clinically relevant overall benefits, is subject to the long-term follow up of the Choice Trial patients.

CA-based Edwards, which globally offers surgical heart valve therapy products, currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks worth considering in the medical products industry include Enzymotec Ltd. ENZY and SurModics, Inc. SRDX.  While Enzymotec carries a Zacks Rank #1 (Strong Buy), SurModics carries a Zacks Rank #2 (Buy).