Boston Scientific Reports Favorable Six-Month Results From Lotus™ Valve System
NATICK, Massachusetts, September 17, 2013
NATICK, Massachusetts, September 17, 2013 /PRNewswire/ --
REPRISE II Data Honored as Best Abstract 2013 at PCR London Valves Course
Boston Scientific Corporation (NYSE: BSX) reported favorable six-month results
from the first 60 patients enrolled in the REPRISE II clinical trial
evaluating the safety and performance of the Lotus™ Valve System in
symptomatic patients with severe aortic stenosis considered at high risk for
surgical valve replacement.
The data, which were presented today at PCR London Valves and formally
received the honor of Best Abstract 2013, demonstrated excellent results with
no new valve-related adverse events between 30 days and six months.
Additionally, there were no cases of moderate or severe paravalvular
regurgitation in any patient at six months.
*Excellent hemodynamic results continue to be observed at six months as
demonstrated by mean aortic valve pressure gradient of 12.1 ± 5.0 mmHg and
mean aortic valve area of 1.8 ± 0.5 cm ^2 .
*Independent core lab assessment of paravalvular aortic regurgitation
showed 76.1 percent of patients presenting with no paravalvular
regurgitation and no cases of moderate or severe regurgitation.
*There were no new valve-related adverse events recorded between 30 days
and six months.
*The NYHA classification data demonstrated a significant improvement in
heart failure symptoms at six months compared to baseline.
"The Lotus Valve System provides the operator with superb control allowing
precise positioning and accurate deployment," said Professor Ian Meredith,
director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and
principal investigator of the REPRISE II trial. "The results from the first 60
patients of the REPRISE II trial are very impressive, especially with no
patients presenting with moderate or severe paravalvular regurgitation at six
The Lotus Valve System is the first transcatheter aortic valve replacement
(TAVR) device of its kind with an Adaptive™ Seal that is designed to minimize
aortic regurgitation (leaking) around the valve, a proven predictor of
mortality, and is both fully repositionable and retrievable prior to release.
Boston Scientific expects to release additional REPRISE II data in late
October at the TCT (Transcatheter Cardiovascular Therapeutics) conference in
"The latest results from REPRISE II underscore the promising and unique
technology behind the Lotus Valve System, demonstrating how the Lotus Valve
System can offer a new treatment alternative for patients with severe aortic
valve disease," said Keith Dawkins, M.D., global chief medical officer, Boston
Scientific."These features help to simplify the implantation procedure and
may lead to improved clinical outcomes."
The Lotus Valve System is an investigational device worldwide and not
available for sale. To view the Multimedia News Release including videos,
backgrounders and images, please click here:
The results of the REPRISE clinical trial program are expected to be used to
support CE Mark and other international regulatory approvals.
About REPRISE II
REPRISE II is an ongoing prospective, single-arm study that has completed
enrollment of 120 patients at 14 sites in Australia, France, Germany and the
United Kingdom. All patients had severe symptomatic aortic stenosis and were
considered at high risk for surgical valve replacement. An additional 130
patients are expected to be enrolled at a total of 20 sites in Australia and
Europe in an extension of REPRISE II.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that
improve the health of patients around the world. As a global medical
technology leader for more than 30 years, we advance science for life by
providing a broad range of high performance solutions that address unmet
patient needs and reduce the cost of healthcare. For more information, visit
http://www.bostonscientific.com and connect on Twitter and Facebook .
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