Boston Scientific Lotus Valve System: Key to Clinical Efficacy - Analyst Blog
Boston Scientific Corporation BSX recently presented initial data from its RESPOND Post-Market Study at EuroPCR 2015, Paris, demonstrating results in favor of its Lotus aortic valve system.
Boston Scientific’s Lotus Valve system is a unique next-generation transcatheter aortic valve implantation (TAVI) device that offers a precise valve placement treatment option for patients with severe aortic stenosis, at high risk of surgery. Its unique features include an Adaptive Seal that minimizes paravalvular aortic leakage (PVL).
We note that aortic stenosis is a common disease that involves dysfunction of the aortic heart valve, and affects 3% of the population over 65 years of age and 5% of those aged over 75.
In June 2014, Boston Scientific had initiated the single arm, multi-center post market study – RESPOND Registry – to evaluate the real world performance of the Lotus Valve System. RESPOND Registry originally aimed at accumulating data on clinical outcomes and device performance from 1,000 patients who had undergone TAVI treatment at 50 centers around the world.
At EuroPCR 2015, 30-day post implantation results for the first 250 patients under this trial demonstrated an exceptionally low PVL rate along with cardiovascular mortality rate of merely 1.6%. More specifically, over 95% of the patients had no or traces of PVL. Less than 5% exhibited mild PVL while cases of moderate or severe PVL were nil.
Management believes the aforementioned study results work in favor of the Lotus Valve System, as the absence of PVL indicates significant long-term survival chances for aortic stenosis patients.
In a separate announcement, Boston Scientific revealed results from the REPRISE II Extended Cohort trial that validated clinical efficacy of the Lotus valve system on similar lines. Statistically, post implantation at 30 days, nearly 86% of the total 250 patients had no or traces of PVL, less than 14% showed mild PVL and less than 1% had moderate PVL. Notably, none of the patients exhibited severe PVL.
Per management, results from both the studies point toward the strong clinical efficacy of the Lotus Valve System, that makes it a revolutionary less invasive treatment option for aortic stenosis patients who are at high risk of surgery.
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 Boston Scientific, backed by its Lotus Valve System, is uniquely positioned to capture a larger share of this growing market in the days ahead.
Zacks Rank
Currently, the stock carries a Zacks Rank #3 (Hold). Some other better-ranked medical products stocks are Bio-Rad Laboratories, Inc. BIO, Hospira Inc. HSP and Vascular Solutions Inc. VASC. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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