Medtronic Announces Reimbursement Approval and Launch of CoreValve(TM) Evolut(TM) R System in Japan
December 01 2016 - 9:30AM
Medtronic
Introduces First-and-Only Recapturable TAVI System Available in
Japan
DUBLIN - Dec. 1, 2016 - Medtronic plc
(NYSE: MDT) today announced it has received reimbursement approval
from the Japanese Ministry of Health, Labor and Welfare (MHLW) for
the recapturable, self-expanding transcatheter CoreValve(TM)
Evolut(TM) R System for patients with severe aortic stenosis (AS)
unable to undergo surgery, and for whom treatment with
transcatheter aortic valve implantation (TAVI) is determined to be
the best option. This approval follows the Shonin approval from the
MHLW the company received in November. The approval is based on
robust data from the CoreValve U.S. Pivotal and CE Mark Clinical
Trials, which demonstrated high rates of survival, low rates of
stroke and excellent hemodynamics.
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 120,000
patients in 60 countries.
"TAVI continues to grow as an established
treatment for inoperable AS patients in Japan and we are excited to
have a next-generation, self-expanding option, as the Evolut-R
system has demonstrated exceptional clinical results in studies
globally," said Yoshiki Sawa, M.D., professor in the Department of
Cardiovascular Surgery at Osaka University Graduate School of
Medicine in Osaka, Japan. "Clinical data show the advancement of
recapturability with Evolut R gives physicians more confidence
during the procedure, providing different advantages not
currently available in other TAVI systems."
The new system consists of the CoreValve Evolut R
transcatheter valve and the EnVeo(TM) R Delivery System, which
features an Enveo R InLine(TM) Sheath that significantly reduces
the profile to the lowest on the market (14 Fr equivalent, less
than 1/5 inch). The Evolut R System, with its self-expanding
nitinol frame, is designed to optimally fit within the native
aortic valve, using its supra-annular valve position to help
achieve excellent hemodynamic performance.
"Heart teams made up of cardiac surgeons and
interventional cardiologists in Japan are making important TAVI
treatment decisions for patients who may benefit from this less
invasive valve replacement procedure, and now having the option to
recapturable and reposition will only help to improve patient
outcomes," added Shigeru Saito, M.D., director of cardiology and
catheterization laboratories at Shonan Kamakura General Hospital in
Kamakura, Japan.
Based on the knowledge gained through extensive
experience with the CoreValve System, the Evolut R is intended to
increase conformability and sealing at the annulus. An extended
sealing skirt on the 26mm and 29mm valve sizes is intended to
further promote valve sealing at the annulus.
"This approval stems from our global commitment to
building a market-leading innovation pipeline in the transcatheter
space, and we look forward to supporting Japanese heart teams as
they look to next-generation technologies to improve valve
performance for a broad range of patients," said Rhonda Robb, vice
president and general manager of the Heart Valve Therapies
business, which is part of the Cardiac and Vascular Group at
Medtronic. "We look forward to introducing this next-generation,
recapturable technology to indicated patients in Japan."
The CoreValve System was the first self-expanding
TAVI system to be approved in Japan in March of 2015.
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
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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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