MARLBOROUGH, Mass.,
Sept. 19, 2016 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) has received CE
Mark for the LOTUS Edge™ Valve System, the company's next
generation transcatheter aortic valve implantation (TAVI)
technology. The LOTUS Edge valve system is indicated for aortic
valve replacement in patients with severe aortic stenosis who are
considered at high risk for surgical valve replacement. Instead of
open heart surgery, the replacement valve is delivered via
transcatheter percutaneous delivery, a minimally invasive procedure
involving a small incision to gain access to a blood vessel.
In comparison to the Lotus™ Valve System, this next iteration
incorporates a more flexible, lower profile catheter designed to
improve ease of use and accommodate tortuous anatomy. Another
differentiating feature of the LOTUS Edge valve system is the
inclusion of Depth Guard™, a design element intended to reduce the
need for a permanent pacemaker (PPM).
"The LOTUS Edge device is a highly anticipated next generation
of the Lotus Valve System," said Professor Ian Meredith, director of MonashHeart, at Monash
Medical Centre in Melbourne,
Australia. "It retains many of its predecessor's unique and
valuable proprietary features, including the ability to reposition
the device precisely and prevent paravalvular leak, while
incorporating new design characteristics such as a more flexible
catheter for easier delivery and Depth Guard™ technology designed
to reduce valve interaction with the conduction system of the heart
during valve deployment."
Leveraging the current Lotus platform, the LOTUS Edge valve
system integrates the Adaptive Seal™ technology which minimizes
paravalvular regurgitation (leaking) or PVL, as demonstrated in the
1,000 patient RESPOND Post-Market Registry. This study found that
91.9% of patients had core-lab adjudicated trace or no PVL
pre-discharge, and 7.7% had mild PVL. No patients had severe PVL
and only 0.3% of patients had moderate PVL. LOTUS Edge continues to
be the only TAVI device that offers controlled mechanical
expansion, which allows the valve to be fully deployed and assessed
and then repositioned or fully retrieved by the physician, if
needed.
"We are steadfast in our commitment to advancing the science
behind TAVI procedures by ensuring clinicians have effective
treatment modalities to provide to their patients with severe
aortic stenosis," said Kevin
Ballinger, president, Interventional Cardiology, Boston
Scientific. "The LOTUS Edge valve system is designed to give
physicians increased control during implantation, which can help
provide a more precise, predictable procedure to ensure the best
patient outcomes."
The LOTUS Edge valve system will be available to select centers
in Europe, with commercial site
expansion accelerating as physicians and centers become fully
trained.
The Lotus Valve System is an investigational device in
the United States and Japan and is not available for sale in those
countries.
Click here to view and download an image of the LOTUS Edge valve
system.
About Aortic Valve Disease
Aortic valve disease
results in dysfunction of the aortic valve, one of the four valves
that control the flow of blood in and out of the heart.
Aortic valve stenosis is the process of thickening and stiffening
of the valve, resulting in restricted valve opening and reduction
in blood flow. Aortic stenosis is a common problem affecting
approximately three percent of the population over age 65 and five
percent of people older than 75. From the onset of aortic stenosis
symptoms, the average survival rate is 50 percent at two years and
20 percent at five years.
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 35 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 www.bostonscientific.com and connect
on Twitter and Facebook.
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CONTACTS:
U.S. Media: Timette Nevala
(763) 494-1284 (office)
Timette.Nevala@bsci.com
European Media: Chiara Ennas
44 1442 411618 (office)
Chiara.Ennas@bsci.com
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CFA
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific Corporation