As TAVI Patient Population Grows, PRO+ TAVI System Launches
with Four Valve Sizes and Lowest Delivery Profile
DUBLIN, May 3, 2021 /CNW/ -- Medtronic plc (NYSE:
MDT), the global leader in medical technology, today announced CE
(Conformité Européenne) Mark of the Evolut™ PRO+ TAVI System – the
newest-generation Medtronic TAVI system that builds off the proven
self-expanding, supra-annular Evolut TAVI platform. The Evolut PRO+
TAVI System includes four valve sizes with an external pericardial
tissue wrap that provides advanced sealing for the largest annular
range (for self-expanding TAVI technology) on the market. The
approval follows a recent indication expansion for the Evolut
platform in Europe for patients
with severe aortic stenosis who are at a low risk of surgical
mortality and patients with bicuspid aortic valves who are at
intermediate, high and extreme risk of surgical mortality.
"As TAVI expands to a broader patient population, including
patients at a low risk of surgical mortality and those with
bicuspid valves, having the right valve technology becomes a
critically important factor in making treatment decisions," said
Haim Danenberg, M.D., Ph.D.,
professor of medicine and head of Interventional Cardiology at
Wolfson Medical Center in Israel.
"Heart teams pursue a valve solution that is safe, effective and
durable. We need a system that can be delivered through the femoral
arteries without losing any feature of efficacy such as reducing
paravalvular leak and achieving excellent hemodynamics. Because of
its design and long track record of exceptional clinical outcomes,
the Evolut TAVI platform is well-suited to meet these needs."
The Evolut PRO+ TAVI System is approved in four valve sizes (the
23, 26 and 29mm systems can access vessels down to 5.0 mm) with the
34 mm system able to access vessels down to 6.0 mm. The system is
designed with an outer porcine pericardial tissue wrap that adds
surface area contact and tissue interaction between the valve and
the native aortic annulus, and includes an integrated, inline
sheath, allowing physicians to treat patients with a range of
anatomical variations with a low delivery profile. Consistent with
the Evolut platform design, the PRO+ valve is designed with a
self-expanding nitinol frame that conforms to the native annulus
with consistent radial force and advanced sealing.
"Anatomical variations can present unique challenges and demand
tailored transcatheter valve selection," said Nicolas Van Mieghem , M.D., Ph.D., professor of
interventional cardiology, department of cardiology, Thoraxcenter,
Erasmus University Medical Center.
"This is the first time European physicians will have access to the
large 34mm Evolut PRO+ valve size that contains an external tissue
wrap for patients with large aortic root dimensions."
Severe aortic stenosis occurs when the aortic valve leaflets
become stiff and thickened and have difficulty opening and closing,
making the heart work harder to pump blood to the rest of the body
and, therefore, impacting an individual's daily activities. If left
untreated, patients with symptomatic severe aortic stenosis can die
from heart failure in as little as two years.
"We believe that continued iteration of the CoreValve/Evolut
family of supra-annular transcatheter aortic valves will result in
progressive improvements in patient outcomes," said Jeffrey J. Popma, M.D., vice president and chief
medical officer for the Coronary & Renal Denervation business
and the Structural Heart and Aortic business, which are part of the
Cardiovascular Portfolio at Medtronic. "The Evolut PRO+ TAVI system
will provide heart teams a valve with strong hemodynamic
performance, with a lower vascular access profile, thereby allowing
more patients to be treated by a transfemoral approach rather than
alternative access methods. The additional pericardial wrap in the
34 mm Evolut PRO+ may also reduce the degree of residual
perivalvular regurgitation."
The Evolut TAVR platform, including the Evolut™ R, Evolut™ PRO
and Evolut PRO+ TAVI Systems, is indicated for symptomatic severe
native aortic stenosis patients across all surgical risk categories
(extreme, high, intermediate and low) in the U.S. and countries
that recognize 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 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 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 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.
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SOURCE Medtronic plc