Medtronic Expands TAVR Access to More Patients With Symptomatic, Severe Aortic Stenosis Upon Intermediate Risk FDA Approval
July 10 2017 - 11:35AM
Self-Expanding
CoreValve(TM) Evolut(TM)TAVR Platform with Excellent Procedural
Safety and Proven Valve Performance Helps Address Needs of
Intermediate-Risk Patients
DUBLIN - July 10, 2017 -
Medtronic plc (NYSE: MDT) today announced the expanded U.S. Food
and Drug Administration (FDA) approval of the self-expanding
CoreValve(TM) Evolut(TM) transcatheter aortic valve replacement
(TAVR) platform to include patients with symptomatic severe aortic
stenosis who are at an intermediate risk for open-heart surgery.
With hemodynamic performance (a measure of blood flow efficiency)
shown to be superior to surgical aortic valve replacement (SAVR),
the CoreValve Evolut platform is designed to deliver excellent
valve performance for these patients who are often considered to be
a more active than high- or extreme-risk patients previously
indicated for the procedure.
Patients who are at intermediate risk for
open-heart surgery have a risk of mortality of >= 3 percent at
30 days following the procedure. The risk assessment is determined
by a heart team (including an interventional cardiologist and
cardiac surgeon), in combination with the Society of Thoracic
Surgeons (STS) score and other factors, such as co-morbidities,
frailty, prior surgical intervention and disabilities.
"As evidenced by the landmark SURTAVI trial, the
CoreValve Evolut platform is well-suited for the intermediate-risk
patient population due to its supra-annular design for unsurpassed
hemodynamics, low rates of mortality and disabling stroke, earlier
improvement in quality of life, fast functional recovery times and
short hospital stays," said Michael Reardon, M.D., professor of
cardiothoracic surgery and Allison Family Distinguished Chair of
Cardiovascular Research at Houston Methodist DeBakey Heart &
Vascular Center. "It's important to consider that in the first 30
days, patients treated with TAVR showed functional improvements and
lower rates of stroke than the surgical patients in the study."
Recently unveiled at the 2017 American College of
Cardiology meeting, the global SURTAVI trial evaluated
intermediate-risk patients and compared 863 TAVR patients treated
with the CoreValve and Evolut R Systems (STS: 4.4 percent) to 794
surgical patients (STS: 4.5 percent). Against the strongest
surgical performance (compared to predicted surgical risk of
mortality) seen to date in a randomized trial, the CoreValve Evolut
platform met its primary endpoint of non-inferiority compared to
surgery in all-cause mortality or disabling stroke (12.6 percent
for TAVR versus 14.0 percent for SAVR; posterior probability of
non-inferiority >0.999). The CoreValve Evolut platform also
demonstrated significantly better mean aortic valve gradients (7.8
mm Hg vs. 11.8 mm Hg; p<0.001) at two years. SAVR was associated
with less aortic regurgitation, major vascular complications and
need for permanent pacemaker implantation.
"Patients at intermediate risk for open-heart
surgery account for a large portion of the severe aortic stenosis
population," said Rhonda Robb, vice president and general manager
of the Heart Valve Therapies business, a part of Medtronic's
Cardiac and Vascular Group. "We are delighted to take the
self-expanding CoreValve Evolut platform to more patients with
aortic stenosis who can benefit from this therapy."
The CoreValve Evolut platform consists of the
CoreValve, CoreValve Evolut R and the recently FDA-approved
CoreValve Evolut PRO systems, which are available for use in the
United States with severe aortic stenosis patients at an
intermediate surgical risk or greater. The CoreValve Evolut PRO
System is currently not approved for commercial use outside of the
United States.
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 91,000 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-
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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