Edwards Lifesciences Presents Positive Data on Sapien3
Renowned heart valve manufacturer Edwards Lifesciences Corp. EW recently revealed positive data from the Source 3 Registry of its Sapien 3 transcatheter heart valve (THV), at the EuroPCR 2016. The trial outcome reflected the highest ever reported survival rate and low stroke rate for aortic stenosis (AS) patients enrolled in the Source family of registries.
The Source 3 registry, which enrolled 1,947 patients across 80 centers in Europe, represents the first large, multi-center report of Sapien 3 valve patient outcomes in a commercial setting. A follow-up of 5 years will be conducted on the patients who were involved in this post-approval study.
Results from this study demonstrated a survival rate of 98.1% and low stroke rate of 1.2% at the end of 30 days, for patients implanted with a Sapien 3 valve.
Interestingly, this news surfaced only a month after Edwards announced favorable results from its Partner II clinical trial. Data from the trial had demonstrated a low rate of all-cause mortality, stroke and moderate or severe aortic regurgitation for AS patients implanted with Sapien 3 valve compared to those who had undergone open heart surgery.
We believe that the results from the Source 3 registry highlight the advantages of Sapien 3 for patients suffering from severe symptomatic AS. This is expected to lead to greater adoption of Sapien 3 valves among AS patients, which in turn, will boost Edwards’ THV business segment sales.
Of late, Edwards Lifesciences has been making significant progress with its Sapien 3 valve promotions, starting from winning the regulatory approvals to marketing the device in Europe in 2014, in the U.S. in 2015 and recently in Japan in Mar 2016.
Notably, the company has also been seeing successful clinical trial results worldwide for this THV. For instance, the latest study results presented at the American College of Cardiology, demonstrated powerful evidence in favor of expanding the Sapien 3 technology to a broader population of AS patients.
Moreover, the Sapien 3 Ultra – a next-generation THV system – is currently on track for CE Mark approval in the fourth quarter of 2016; which is expected to enhance ease-of-use, reduce possible complications and shorten procedure time while performing transcatheter aortic valve replacement (TAVR).
It is worth mentioning in this context that in recent years, the global TAVR market has witnessed rapid growth owing to increasing old age population, growing obesity conditions and an increase in AS patient count. With the global TAVR market estimated to be worth more than $5 billion by 2021, we expect the aforementioned developments to allow Edwards garner higher profits from its THV portfolio, going ahead.
The company currently sports a Zacks Rank #1 (Strong Buy). Other favorably ranked medical stocks are SurModics, Inc. SRDX, Baxter International Inc. BAX and Boston Scientific Corporation BSX. While SurModics sports a Zacks Rank #1, Baxter and Boston Scientific carry a Zacks Rank #2 (Buy).
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