Landmark SURTAVI Clinical Trial Shows Transcatheter Aortic Valve Replacement (TAVR) with the Self-Expanding Platform Performs...
March 17 2017 - 9:00AM
Late-Breaking
SURTAVI Pivotal Clinical Trial Presented at ACC.17 and Published in
NEJM Meets Primary Endpoint at Two Years
DUBLIN and WASHINGTON, D.C. -
March 17, 2017 - Medtronic plc (NYSE: MDT) today unveiled
first-ever clinical data from the Surgical Replacement and
Transcatheter Aortic Valve Implantation (SURTAVI) Trial, which was
presented at the American College of Cardiology (ACC) 66th Annual
Scientific Session and published simultaneously in The New England Journal of Medicine
(NEJM)1.
Data from the trial showed the Medtronic
self-expanding TAVR platform met its primary endpoint of all-cause
mortality or disabling stroke at two years. Rates of all-cause
mortality or disabling stroke at two years were similar to surgical
aortic valve replacement (SAVR) (12.6 percent for TAVR versus 14.0
percent for SAVR; posterior probability of
non-inferiority >0.999). The minimally-invasive TAVR
procedure also demonstrated significantly better mean aortic valve
gradient (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years, while neither TAVR- nor
SAVR-treated patients displayed evidence of structural valve
deterioration at two years.
"We observed excellent outcomes in both arms of
the study and were pleased to see the self-expanding platform
perform as well as the gold standard of surgery in this
intermediate risk patient population," said Michael Reardon, M.D.,
professor of cardiothoracic surgery and Allison Family
Distinguished Chair of Cardiovascular Research at Houston Methodist
DeBakey Heart & Vascular Center, principal investigator and
author of the SURTAVI trial. "Importantly, near-term results showed
critical insights for the therapy. In the first 30 days, patients
treated with TAVR experienced statistically lower rates of stroke,
lower rates of new onset atrial fibrillation, a quicker hospital
discharge, less acute kidney injury and transfusions, and an
improved quality of life. SAVR was associated with less aortic
regurgitation, major vascular complications and need for permanent
pacemaker implantation."
The SURTAVI trial is a global, prospective,
multi-center, randomized study evaluating the Medtronic
CoreValve(TM) System and CoreValve(TM) Evolut(TM) R System versus
open-heart surgery at two years. The SURTAVI trial enrolled
intermediate risk patients and compared 863 TAVR patients (STS: 4.4
percent) to 794 SAVR patients (STS: 4.5 percent).
"This is a landmark trial demonstrating our
commitment to generating clinical evidence to support the expansion
of global patient access to life-changing therapies such as TAVR,"
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 are delighted to have met the primary
endpoint in the SURTAVI trial, the results of which have been
submitted to the FDA to support an intermediate risk label
expansion."
The use of the CoreValve and Evolut R systems in
intermediate risk severe aortic stenosis patients is
investigational only in the U.S.
Following the launch of the self-expanding
CoreValve System in the U. S. in 2014, the CoreValve Evolut R
System became the first-and-only recapturable and repositionable
TAVR device approved in the U.S. for severe aortic stenosis
patients at a high or extreme risk for surgery in 2015. The Evolut
R system received CE (Conformité Européene)
Mark for intermediate risk severe aortic stenosis patients in
2016.
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 more than 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-
1 Reardon
MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter
aortic-valve replacement in intermediate-risk patients. N Engl J Med. DOI: 10.1056/NEJMoa1700456.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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