Medtronic Announces Japanese Regulatory Approval of CoreValve® System
31 March 2015 - 12:07AM
DUBLIN - March 30, 2015 - Medtronic plc (NYSE: MDT) today
announced Japanese regulatory approval for the self-expanding
transcatheter CoreValve® System for
patients with severe aortic stenosis (AS) unable to undergo
surgery, and for whom treatment with the CoreValve is determined to
be the best option. Japanese regulatory authorities granted
approval of the CoreValve system for transcatheter aortic valve
implantation (TAVI) based on robust data from the CoreValve U.S.
Pivotal Trials and the Medtronic CoreValve Japan Trial, which is
the first study to evaluate a self-expandable transcatheter valve
in the Japanese patient population.
"We are excited to be able to offer this new
option for our patients, as the CoreValve system has demonstrated
exceptional clinical results in studies globally as well as in
Japan," said Yoshiki Sawa, M.D., professor in the Department of
Cardiovascular Surgery at Osaka University Graduate School of
Medicine in Osaka, Japan. "Physicians in Japan should have
confidence in making TAVI treatment decisions for patients who may
benefit from a less invasive valve replacement procedure with this
proven self-expandable valve."
Data from the Extreme and High Risk Studies in the
CoreValve U.S. Pivotal Trial demonstrated that the CoreValve System
is safe and effective with high rates of survival and some of the
lowest rates of stroke and valve leakage reported. The CoreValve
System, with a supra-annular valve design, has also achieved
hemodynamics, or blood flow, post-implant with results similar to
the gold standard, surgical valves.
The Medtronic CoreValve Japan Trial confirmed the
performance of CoreValve shown in the U.S. Pivotal Trial. At 6
months, 91.7 percent of the transfemoral (TAVI procedure through
the femoral artery) patients in the Japan trial met the primary
endpoint of improvement of at least one New York Heart Association
class (measures severity of heart failure symptoms) and aortic
valve area (measures the severity of aortic stenosis) greater than
1.2 cm2. For
all patients in the trial, freedom from all-cause mortality at 6
months was 90.8 percent. The trial also demonstrated functional and
anatomical effectiveness of CoreValve.
The CoreValve self-expanding nitinol frame enables
physicians to deliver the device to the diseased valve in a
controlled manner, allowing for accurate placement. Valves are
delivered via the smallest (18Fr, or approximately 1/4 inch)
TAVR delivery system available, making it possible to treat
patients with difficult or small vasculature.
"Medtronic has been committed to bringing this
life-saving therapy to patients in Japan. The feedback from heart
teams around the world using CoreValve has been overwhelmingly
positive and we are confident that Japanese physicians will embrace
the therapy," 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 working with
Japan's Ministry of Health, Labor and Welfare to gain reimbursement
for CoreValve, and to initiating comprehensive training and
education programs to support heart teams so that more patients may
benefit from this break-through technology."
Since receiving CE (Conformité Européenne) Mark in
2007, the CoreValve System has been implanted in more than 75,000
patients in more than 60 countries. The CoreValve System was
approved by the FDA for patients at extreme risk in January 2014,
and approved for high risk patients in June 2014. The
next-generation recapturable CoreValve Evolut R transcatheter valve
and the CoreValve EnVeo R Delivery Catheter System are available in
Europe and other countries that recognize the CE 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
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information contained therein.
Source: Medtronic plc via Globenewswire
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