MARLBOROUGH, Mass.,
Sept. 28, 2020 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) today announced
it has initiated a controlled launch of the ACURATE neo2™
Aortic Valve System in Europe.
This next-generation transcatheter aortic valve implantation (TAVI)
technology is a new platform designed with a number of features to
improve upon the clinical performance of the original ACURATE
neo platform. Compared to the previous generation device,
the ACURATE neo2 valve system also has an expanded
indication for patients with aortic stenosis – with no specified
age or risk level – who are considered appropriate candidates for
the therapy by their heart team, including a cardiac surgeon.
Indicated to restore function and normal blood flow through a
severely narrowed aortic valve, the ACURATE neo2 Valve
System features a new annular sealing technology designed to
conform to irregular, calcified anatomies and further minimize
paravalvular regurgitation or leaking (PVL). In addition, the
delivery system simplifies access to smaller and complex vessels at
the entry site and allows for highly accurate valve positioning
while the top-down deployment mechanism further supports stable
placement and release to ensure the best patient outcomes.
"We believe having this differentiated valve with the enhanced
sealing technology will further drive favorable market experience
and growth," said Joe Fitzgerald,
president, Interventional Cardiology, Boston Scientific. "Combined
with the LOTUS Edge™ Aortic Valve System and SENTINEL™
Cerebral Protection System to protect the brain against the risk of
TAVI-related stroke, the ACURATE neo2 valve represents the
natural evolution of our complementary dual-valve TAVI toolkit that
covers the needs of a wide range of patient cases."
Data from the ACURATE neo2 CE-Mark Study demonstrated PVL rates for the
ACURATE neo2 Valve System to be lower than previously
reported with the current generation ACURATE neo valve. At
30 days and 1 year after implantation, respectively, 97% and 97.5%
of patients experienced ≤ no/trace or mild PVL, 3.0% and 2.5% of
patients experienced moderate PVL and 0% of patients experienced
severe PVL.1,2
"We are pleased to bring the latest iteration of ACURATE
technology to market, offering design improvements that further
support procedural performance and optimal outcomes for patients
with severe symptomatic aortic stenosis, from those with simple to
the most challenging anatomies," said Dr. Ian Meredith, AM, executive vice president and
global chief medical officer, Boston Scientific. "The
straightforward implant procedure also enables physicians to reduce
the length of time patients need to stay in the hospital, without
compromising on safety and clinical results."
The ACURATE neo2 Aortic Valve System received CE Mark in
April 2020. In the U.S., the ACURATE
neo2 Valve System is an investigational device being
assessed in the ACURATE IDE clinical trial and is not available for
sale.
For more information about the ACURATE neo2 Valve System,
please visit www.bostonscientific.eu/acurateneo2.
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 in the
valve, which can result in an abnormal narrowing of the aortic
valve opening and reduction in blood flow. Aortic stenosis is the
most common valvular heart disease in the world, affecting
approximately 7 percent of the population over age 65.3
From the onset of severe aortic stenosis symptoms, the average
survival rate is 50 percent at two years and 20 percent at five
years without aortic valve replacement.4,5
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 40 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.
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
"anticipate," "expect," "project," "believe," "plan," "estimate,"
"intend" and similar words. These forward-looking statements
are based on our beliefs, assumptions and estimates using
information available to us at the time and are not intended to be
guarantees of future events or performance. These
forward-looking statements include, among other things, statements
regarding our business plans, product launches, and product
performance and impact. If our underlying assumptions turn
out to be incorrect, or if certain risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections expressed or implied by our
forward-looking statements. These factors, in some cases,
have affected and in the future (together with other factors) could
affect our ability to implement our business strategy and may cause
actual results to differ materially from those contemplated by the
statements expressed in this press release. As a result,
readers are cautioned not to place undue reliance on any of our
forward-looking statements.
Factors that may cause such differences include, among other
things: future economic, competitive, reimbursement and regulatory
conditions; new product introductions; demographic trends;
intellectual property; litigation; financial market conditions; and
future business decisions made by us and our competitors. All
of these factors are difficult or impossible to predict accurately
and many of them are beyond our control. For a further list
and description of these and other important risks and
uncertainties 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 Factors in
Quarterly Reports on Form 10-Q we have filed or will file
hereafter. We disclaim any intention or obligation to
publicly update or revise any forward-looking statements to reflect
any change in our expectations or in events, conditions or
circumstances on which those expectations may be based, or that may
affect the likelihood that actual results will differ from those
contained in the forward-looking statements. This cautionary
statement is applicable to all forward-looking statements contained
in this document.
CONTACTS:
Angela Mineo
Media Relations
(763) 955-8325 (office)
Angela.Mineo@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
1 Transcatheter aortic valve implantation for
severe aortic valve stenosis with the ACURATE neo2 valve
system:30-day safety and performance outcomes. Presented by H.
Möllmann at PCR London Valves 2018.
2 Transcatheter aortic valve replacement with the
ACURATE neo2 valve system:1-year clinical and hemodynamic outcomes.
Presented by H. Möllmann at TVT 2019.
3 Arora S, et al. "Transcatheter Aortic Valve
Replacement: Comprehensive Review and Present Status." Tex Heart
Inst J. 2017; 44(1):29-38.
4 Ramaraj R and V.L. Sorrell. "Degenerative Aortic
Stenosis." BMJ. 2008; 336(7643):550-555.
5 Lester, S.J. et al. CHEST 1998; 113:1109-14.
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SOURCE Boston Scientific Corporation