Boston Scientific Corporation
) announced positive results from the Reprise I feasibility trial
at the Euro PCR in Paris. The study evaluated the safety of the
Lotus valve system, a transcatheter aortic valve replacement
('TAVR') device, in patients with severe aortic valve disease.
In April 2012, enrollment (of 11 patients at 3 sites in
Australia) was completed in the Reprise I clinical trial.
Successful implantation of the device without in-hospital major
adverse cardiovascular or cerebrovascular events (MACCE) through
discharge or seven days post-procedure (whichever comes first) was
the primary endpoint. The selected patients had severe symptomatic
aortic stenosis and were considered at high risk for surgical valve
replacement. No in-hospital MACCE (in 91% of the patients) or
mortality was observed. However, one patient suffered a stroke. No
moderate or severe paravalvular regurgitation was present after
valve placement or at discharge.
The Lotus valve came to be included in the portfolio of Boston
Scientific following the acquisition of Sadra Medical in
2011. During the third quarter of 2012, the company plans to
enroll another batch of 120 patients at up to 15 sites in Australia
and Europe in the Reprise II study, scheduled to be completed in
the first half of 2013. The Reprise II study will evaluate the
safety and performance of the Lotus valve, data from which will be
used to support CE Mark regulatory approval, anticipated in the
second half of 2013.
Boston Scientific also announced data from the Evolve trial. It
was observed that the Synergy stent was non-inferior in treating
coronary artery lesions at one year compared to Promus Element. The
trial reported one-year clinical and six-month intravascular
ultrasound (IVUS) outcomes data, evaluating the safety and
effectiveness of the Synergy stent.
Despite the innumerable headwinds in its core segments of stents
and defibrillators, Boston Scientific is working on portfolio
expansion. Other players in the medical devices space, such as
St Jude Medical
), are also engaging in various alternatives to revive their
flagging top line. Successful commercialization of the new
technologies is expected to boost the company's top line in the
We have a Neutral recommendation on Boston Scientific. The stock
retains a Zacks #3 Rank (hold) in the short term.
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