Edwards Lifesciences Corporation EW recently presented 30-day data from its SAPIEN 3 Trial at EuroPCR 2015, in favor of its SAPIEN 3 transcatheter aortic valve. The data reinforces Edwards’ strong focus on expanding its footprint in the multi-billion transcatheter heart valve (THV) market.
Under this prospective, multicenter, non-randomized trial, 101 intermediate-risk patients were administered transfemoral treatment with the SAPIEN 3 THV at 13 centers in Europe and Canada. Per the results, all members of the patient group exhibited very low mortality and stroke rates. Further, there were zero cases of severe paravalvular leakages (PVLs) and only 2.3% of moderate PVLs.
Moreover, all-cause mortality in this study was only 1% with disabling stroke rate of only 2%. Also, among all the patients, merely 2% suffered from major vascular complications while only 4% were in need of a permanent pacemaker.
Interestingly, this news came to the fore on the same day as Boston Scientific’s BSX positive trial results presented in favor of its Lotus Aortic Valve System. We believe this places Edwards on par with its rival in the highly competitive THV market.
A day prior to this announcement, Edwards had reported 1-year outcome from the SAPIEN 3 trial, involving the first 150 patients treated with the SAPIEN 3 valve during Jan–Nov 2013 at 16 centers across Europe and Canada.
According to this particular outcome, 91.6% of the patients survived with only 1.1% experiencing disabling stroke. Also, only 2% of the patients had moderate PVLs, while none suffered from severe PVLs.
Incidentally, these independent set of data are in accordance with the outcomes that Edwards recently reported from a similar study that involved 1,000 patients treated at 51 centers in the U.S. This clearly validates the clinical efficacy of the SAPIEN 3 heart valve in minimizing PVLs, uniformly across the globe.
The SAPIEN 3 valve had been commercially approved in Europe in Jan 2014 for use in high-risk and non-operable patients suffering from severe aortic stenosis. However, it is yet to receive commercial clearance for use in intermediate-risk patients in any country and is currently under investigation for the same in the U.S. Once this approval is granted, a rise in demand for SAPIEN 3 in the U.S. can be easily expected.
According to research and consulting firm GlobalData, the global market value for transcatheter heart valves will expand at a compound annual growth rate (CAGR) of 19.7% through 2020, to reach an approximate $3.02 billion. In such a scenario, we believe Edwards, backed by its SAPIEN 3 heart valve, is well positioned to capture a larger share of this growing market in the days ahead.
Currently, both Edwards and Boston Scientific carry a Zacks Rank #3 (Hold). Some better-placed medical instruments stocks are LDR Holding Corporation LDRH and RTI Surgical Inc. RTIX. Both these stocks sport a Zacks Rank #1 (Strong Buy).
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