Medtronic Announces FDA Approval for New TAVR System, Introduces First and Only Recapturable Heart Valve in U.S.
June 23 2015 - 9:27AM
CoreValve®
Evolut(TM) R Recapturable and Repositionable Heart Valve Improves
Positioning Accuracy and Control During Deployment
DUBLIN - June 23, 2015 -
Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug
Administration (FDA) approval and U.S. launch of the new
recapturable, self-expanding CoreValve® Evolut(TM) R System. The
first-and-only recapturable and repositionable device available in
the U.S., the Evolut R System is approved for transcatheter aortic
valve replacement (TAVR) in severe aortic stenosis patients who are
at high or extreme risk for surgery. Untreated, aortic valve
stenosis can lead to serious heart problems including heart failure
and even death.
Designed to treat patients with aortic stenosis, a
condition where the aortic valve narrows thereby limiting blood
flow from the aorta to the rest of the body, the CoreValve Evolut R
System is built on the proven foundation and procedural success of
the CoreValve System, which has been implanted in more than 75,000
patients in 60 countries.
"In a short time, the TAVR procedure has become an
established treatment option for high risk patients with severe
aortic stenosis who are unable undergo surgery, and physicians are
looking to technology advancements to help deliver even better
patient outcomes," said Mathew Williams, M.D., co-primary
investigator for the study, as well as chief of Adult Cardiac
Surgery and director of Interventional Cardiology and Structural
Heart at the NYU Langone Medical Center in New York City. "Clinical
data have shown the best patient outcomes are achieved when the
valve is properly positioned. The advancement of recapturability
with Evolut R gives physicians more confidence during the procedure
and provides advantages that are non-existent in other TAVR
systems."
The new system consists of the CoreValve Evolut R
transcatheter valve and the EnVeo(TM) R Delivery System, which
features an InLine(TM) Sheath that significantly reduces the
profile to the lowest on the market (14 Fr equivalent, less than
1/5 inch). A smaller profile size provides a greater opportunity to
treat an expanded patient population with smaller vessels (down to
5.0 mm), through the preferred transfemoral access route, which may
minimize the risk of major vascular complications in some
patients.
Based on the knowledge gained through the
extensive experience with the CoreValve System, the Evolut R is
optimized to increase conformability and sealing at the annulus,
while maintaining supra-annular valve positioning for improved
blood flow and hemodynamic performance. An extended sealing skirt
on the 26mm and 29mm valve sizes is intended to further promote
valve sealing at the annulus.
"The FDA approval of Evolut R marks a significant
milestone for Medtronic and TAVR, and ushers in a new era in
transcatheter aortic valves with advanced, recapturable
capabilities," said Rhonda Robb, vice president and general
manager, Heart Valve Therapies, Medtronic. "This approval is an
outcome of our commitment to building a market-leading innovation
pipeline in the transcatheter space, and we look forward to
supporting heart teams as they look to next-generation technologies
that optimize valve performance for a broad range of patients."
The approval of Evolut R as the first
self-expanding, recapturable transcatheter heart valve available in
the U.S. follows other significant milestones reached in recent
months showcasing the company's leadership in the TAVR market. In
March, the CoreValve System was the first TAVR system to be
approved in the U.S. for valve-in-valve (VIV) procedures in
patients whose surgical aortic heart valves have failed. Also
in March, the highly anticipated two-year data from the High Risk
Study of the CoreValve U.S. Pivotal Trial was presented at ACC.15,
which showed superior survival benefit at two years for TAVR with
the CoreValve System compared to patients who underwent surgical
aortic valve replacement (SAVR).
The 23 mm, 26 mm and 29 mm sizes of the CoreValve
Evolut R transcatheter valve and the CoreValve EnVeo R Delivery
Catheter System are available for use in the United States. The
device is also available in Europe and other countries that
recognize the CE (Conformité Européene) mark.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers
and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is the global leader in medical technology - alleviating
pain, restoring health and extending life for millions of people
around the world.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Jeff Warren
Investor Relations
+1-763-505-2696
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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