DUBLIN, Aug. 24, 2021 /CNW/ -- Medtronic plc (NYSE:
MDT), the global leader in medical technology, today announced U.S.
Food and Drug Administration (FDA) approval of its
newest-generation, self-expanding transcatheter aortic valve
replacement (TAVR) system, the Evolut™ FX TAVR system. Designed to
enhance ease-of-use and provide greater precision and control
throughout the procedure, the Evolut FX system maintains the
industry-leading hemodynamic (blood flow) and durability benefits
of the Evolut platform, while bringing product and procedure
innovation for patients with symptomatic severe aortic
stenosis.
The Evolut FX system incorporates the same supra-annular valve
design that has shown hemodynamic performance superior to surgical
aortic valve replacement (SAVR) across large-scale, randomized
clinical trials. The fourth-generation Evolut technology is
equipped with gold markers built into the frame to provide
implanters with direct visualization of depth and valve leaflet
location during implant. In addition, the Evolut FX system
incorporates a redesigned catheter tip for a smoother insertion
profile, a more flexible delivery system that allows for 360-degree
freedom of motion, with a stable, predictable deployment. Like its
predecessor (Evolut PRO+), the newest system includes four valve
sizes for the largest indicated patient treatment range and the
lowest delivery profile currently on the market.
"The self-expanding, supra-annular Evolut platform has evolved
considerably over time and has brought heart teams innovative
features like recapturability, an expanded size matrix, and
advanced valve sealing to help minimize paravalvular leak. Today,
the Evolut FX system further refines a trusted platform with key
product and procedural enhancements that make the self-expanding
system easier to use with enhanced visualization capabilities for
orientation and depth," said Jeffrey
Popma, M.D., vice president and chief medical officer for
the Coronary & Renal Denervation business and the Structural
Heart & Aortic business, which are part of the Cardiovascular
Portfolio at Medtronic.
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.
Severe aortic stenosis often reduces a patient's quality of life
and limits their daily activities. If left untreated, patients with
symptomatic severe aortic stenosis can die from heart failure in as
little as two years.
The Evolut TAVR platform (including the Evolut™ R, Evolut™ PRO,
Evolut PRO+, and Evolut FX) is indicated for symptomatic severe
aortic stenosis patients across all risk categories (extreme, high,
intermediate and low) in the U.S. Limited commercial release is
planned for the fall with a full launch anticipated in early
2022.
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