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Edwards Lifesciences Up on Positive PARTNER II Trial Data

Shares of renowned heart valve manufacturer, Edwards Lifesciences Corp. EW, surged 19.5% to reach $107.48 yesterday, following the release of favorable results for its Sapien family of valves, in the company’s PARTNER II clinical trial. Edwards recently unveiled the trial outcomes for both its SAPIEN XT and SAPIEN 3 transcatheter heart valves (THVs) at the American College of Cardiology's 65th Annual Scientific Session. The results were also published online in The New England Journal of Medicine.

The PARTNER II trial was started by Edwards in 2011, to evaluate the safety and effectiveness of its SAPIEN XT and SAPIEN 3 THVs as well as their individual delivery systems, in treating patients suffering from symptomatic severe aortic stenosis (AS).

Interestingly, AS is a medical condition that occurs when the aortic valve in a patient’s heart narrows compared to its normal size. In such patients, a heart valve replacement is an ideal option. However, those at risk of open surgery benefit more when implanted with a THV like Sapien 3 or Sapien XT.

We believe favorable results from the PARTNER II trial will further enhance Edwards’ revenues from THVs, which grew 38% globally last year; exceeding management’s growth projection of 15-25%.

In estimating the efficacy of the Sapien XT valve, the composite primary endpoint was all-cause mortality or disabling stroke at two years. On the other hand, for evaluating the Sapien 3 valve, the composite primary endpoint included mortality, stroke and moderate or severe aortic regurgitation; as well as individual assessments of all-cause mortality and stroke, at one year.

In the Sapien XT-involved trial, 2,032 patients at 57 centers across the U.S. and Canada were randomly offered surgery or transcatheter aortic valve replacement (TAVR) through a Sapien XT valve implantation. Per the trial outcome, the event rate was 19.3% for TAVR patients implanted with SAPIEN XT compared to 21.1% for surgery patients.  

Similarly, 1,078 patients were randomized across 51 centers in the U.S. and Canada for the trial involving the Sapien 3 valve. Per the results, the all cause mortality and disabling stroke rate was 2% for TAVR patients, lower than 8% for surgery patients.  

Moreover, through this study, Edwards demonstrated TAVR’s ability to significantly shorten ICU and hospital stays, as well as the clinical advantage offered by Sapien XT in patients who are candidates for transfemoral access.

In this context, we note that the TAVR procedure has lately emerged as a convenient and popular treatment option for severe aortic stenosis patients who are practically inoperable. It is estimated that by 2050, 17% of the global population will be over the age of 65 – thereby increasing the patient pool for aortic stenosis.

The PARTNER II trial outcomes indicate better business scope for Edwards in the coming years, particularly with the global TAVR market projected to reach $5 billion by 2021.

Incidentally, Edwards released these results alongside Medtronic plc MDT, which also unveiled new three-year clinical outcomes from its High Risk Study of the CoreValve U.S. Pivotal Trial. The study results proved the superiority of its CoreValve TAVR System over open-heart surgery in high-risk AS patients.

So far Medtronic’s CoreValve system has been implanted in over 100, 000 patients worldwide while Edwards’ Sapien family of valves benefits more than 150, 000 patients. This clearly pinpoints the latter’s competitive leverage in the TAVR market at the moment. Nevertheless, competition is strong and is here to stay over the long run.

Edwards holds a Zacks Rank #2(Buy), while Medtronic currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector are LeMaitre Vascular, Inc. LMAT and Orthofix International N.V. OFIX. Both these stocks sport a Zacks Rank #1 (Strong Buy).

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