Boston Scientific Corporation
) has launched the RESPOND Post Market Registry to evaluate the
real world performance of the Lotus Valve System - a differentiated
second generation transcatheter aortic valve implantation (TAVI)
Following the news, Boston Scientific's share price gained 1.1%
to eventually close at $13.18 yesterday.
The RESPOND Registry will accumulate data on clinical outcomes
and device performance from 1,000 patients who have been implanted
with the aforementioned valve at 50 centers around the world.
So far, 3 patients enrolled in the RESPOND Registry have been
successfully implanted with the Lotus Valve System. This particular
valve system simplifies the TAVI procedure with its ability to
estimate valve functionality fully before release, thereby ensuring
optimal valve implantation.
The first TAVI procedure at Erasmus Medical Center in Rotterdam,
the Netherlands was conducted by two physicians, Dr. Nicolas Van
Mieghem and Prof. Peter De Jaegere, using the Boston Scientific
Safari Pre-Shaped TAVI Guidewire. The Safari Guidewire, compatible
with the Lotus Valve System and other TAVI devices, has received
the U.S Food and Drug Administration (FDA) clearance and CE Mark in
2013 and is designed to provide stable, atraumatic valve
The RESPOND Registry is a prospective, open label, single arm,
multi-center, observational post market study. Clinical
follow-up is at discharge, 30 days, 12 months and annually through
The RESPOND Registry will entail analysis of the
echocardiographic images collected from the patients by an
independent core laboratory, and examination of key clinical events
by an independent clinical events committee. Such measures are
aimed at improving the quality of the collected data and addressing
inconsistencies that are usually noticed in case of site-reported
data in post market studies.
The Lotus Valve System offers a unique precise valve placement
treatment for patients with severe aortic stenosis at high risk of
surgery. It allows for implantation without the need for temporary
pacing at the time of deployment.
Its unique features include an Adaptive Seal that minimizes
paravalvular leakage. This has already been confirmed in the
results of the REPRISE clinical program.
The 6-month clinical study outcomes of REPRISE II, presented at
EuroPCR 2014 in Paris, validated that only 1.1% of patients
implanted with the Lotus valve system are having moderate
paravalvular aortic regurgitation (leaking). At present,
REPRISE II is evaluating the Lotus Valve System in symptomatic
high-risk surgery patients with severe aortic valve stenosis.
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Better-ranked Medical Products stocks that warrant a look
). All the three stocks carry a Zacks Rank #2 (Buy).
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