MARLBOROUGH, Mass., Aug. 27,
2024 /PRNewswire/ -- Boston Scientific Corporation
(NYSE: BSX) today announced it has obtained CE mark for the ACURATE
Prime™ Aortic Valve System, the newest transcatheter aortic valve
replacement (TAVR) technology in the company's structural heart
portfolio. The ACURATE Prime valve system is designed with several
features to build upon the clinical performance of the
ACURATE neo2™ platform including an additional valve
size, which expands the treatment range to patients with a larger
anatomy.
The new ACURATE Prime valve system is indicated to restore
function and normal blood flow through a narrowed aortic valve in
low, intermediate and high-risk patients with severe aortic
stenosis. With a self-expanding, supra-annular design, this device
has an enhanced frame that equalizes force across the valve for a
stable fit against the native, diseased valve. It also offers
physicians a redesigned deployment mechanism for highly accurate
valve positioning to help ensure positive patient outcomes.
"The introduction of the ACURATE Prime technology offers
physicians a TAVR option designed for streamlined procedural
preparation, improved performance in complex cases and simplified
delivery for quick and controlled deployment," said Janar Sathananthan, M.D., chief medical officer,
Interventional Cardiology Therapies, Boston Scientific. "Further,
our clinical experience with the valve to date has shown the
ability for precise positioning of the device in a broader
population of patients, allowing more clinicians to consider this
technology for treatment in challenging or larger heart
structures."
The ACURATE Prime valve system will now be available for the
treatment of aortic annulus diameters between 20.5 and 29 mm. It
will also carry through many of the design features and clinical
outcomes demonstrated in global studies with the ACURATE
neo2 platform, including low pacemaker and paravalvular leak
rates,1,2 strong hemodynamic performance,1 as
well as unrestricted coronary access for future procedures.
"We are thrilled to offer physicians a new valve with meaningful
improvements for the treatment of an increasing number of patients
with aortic valve disease," said Lance
Bates, senior vice president and president, Interventional
Cardiology Therapies, Boston Scientific. "Built on the ACURATE
valve platform, which has been implanted in nearly 80,000 patients
globally to date, the ACURATE Prime valve system is engineered to
improve long-term cardiac function and provide access for future
treatment needs, thereby supporting the lifetime management of
these patients."
The company will initiate the launch of the ACURATE Prime valve
system in Europe in the coming
weeks. For more information on the system,
visit https://www.bostonscientific.com/en-EU/medical-specialties/structural-heart/tavi-acurate-prime.html.
*In Europe, the ACURATE neo2™ Aortic Valve System and the
ACURATE Prime™ Aortic Valve System are CE-marked. In the
USA, the ACURATE neo2
Aortic Valve System and the ACURATE Prime Aortic Valve System are
investigational devices and are restricted under federal law to
investigational use only. Not available for sale.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
technologies that improve the health of patients around the world.
As a global medical technology leader for more than 45 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 health care. Our portfolio of devices and
therapies helps physicians diagnose and treat complex
cardiovascular, respiratory, digestive, oncological, neurological
and urological diseases and conditions. Learn more at
www.bostonscientific.com and connect
on LinkedIn and X, formerly
Twitter.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like
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that may affect our future operations, see Part I, Item 1A
– Risk Factors in our most recent Annual Report on
Form 10-K filed with the Securities and Exchange Commission, which
we may update in Part II, Item 1A – Risk
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CONTACTS:
Angela Mineo
Media Relations
+1 (763) 955-8325
Angela.Mineo@bsci.com
Jon Monson
Investor Relations
+1 (508) 683-5450
BSXInvestorRelations@bsci.com
1 Rück A, Kim WK, Abdel-Wahab M, et al. The Early
neo2 Registry: Transcatheter Aortic Valve Implantation with ACURATE
neo2 in a European Population. J Am Heart Assoc. 2023
Aug;12(15):e029464.
2 Kim WK, Tamburino C, Möllmann H, et al. Clinical
outcomes of the ACURATE neo2 transcatheter heart valve: a
prospective, multicenter, observational, post-market surveillance
study. EuroIntervention. 2023 May 12;19(1):83-92.
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SOURCE Boston Scientific Corporation