Medtronic Announces FDA Approval of New Recaptureable TAVR System Available for Severe Aortic Stenosis Patients with Large An...
October 26 2016 - 1:15PM
Launch of 34 mm
Self-Expanding Evolut R Device Expands TAVR Treatment to Patients
Who Could Not be Treated Previously
DUBLIN - Oct. 26, 2016
- Medtronic plc (NYSE:MDT) today announced the
U.S. Food and Drug Administration (FDA) approval and U.S. launch of
the CoreValve(TM) Evolut(TM) R 34 mm valve-the largest sized
transcatheter aortic valve replacement (TAVR) system available in
the U.S. The new Evolut R 34 mm valve is approved for severe aortic
stenosis patients who are at high or extreme risk for surgery with
an annulus size ranging from 26-30 mm. This large valve segment is
estimated to account for approximately 25-30 percent of the
eligible global TAVR patient population. Previously, some of these
patients were unable to receive a TAVR due to the larger size of
their native diseased aortic valve.
"We're pleased to have more options to offer
patients suffering from severe aortic stenosis who are at high risk
or unable to have open-heart surgery," said Mathew Williams, M.D.,
co-primary investigator for the Evolut 34mm Clinical Study, and
chief of Adult Cardiac Surgery and director of Interventional
Cardiology and the Heart Valve Program at the NYU Langone Medical
Center in New York City. "This new, larger valve offers patients
with larger anatomical structures access to TAVR. For physicians,
the recapturable and repositionable Evolut R can lead to increased
accuracy in placement and control during the procedure."
The Evolut R 34mm valve is delivered through the
EnVeo(TM) R Delivery Catheter System, which features an InLine
Sheath. The system delivers the lowest, true delivery profile
currently on the market (16 Fr equivalent, approximately 1/5 inch),
which provides a greater opportunity to treat patients with smaller
vessels through the preferred transfemoral access route. The Evolut
R System, with its self-expanding nitinol frame, is designed to fit
within the native aortic valve, using its supra-annular valve
position to help achieve excellent hemodynamic performance.
"Heart teams can now use the Evolut R platform to
treat the broadest annulus range in the U.S. market. The approval
of the 34mm valve expands the patient population that can now
receive this minimally invasive treatment alternative to open heart
surgery," said Rhonda Robb, vice president and general manager of
the Heart Valve Therapies business, a part of Medtronic's Cardiac
and Vascular Group. "We look forward to working with physicians and
heart teams across the U.S. to provide this valve to the many
patients who need it."
The CoreValve Evolut R 34 mm valve is only
approved in the United States and not approved in Europe and
other countries.
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 among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
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
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
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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