Medtronic CoreValve® System Receives FDA Approval for Transcatheter Valve-In-Valve Procedures
March 31 2015 - 8:30AM
First TAVR
Device Indicated for Replacement of Failed Surgical Heart Valves
Expands Patient Population That Can Benefit from Minimally Invasive
Procedure
DUBLIN - March 31, 2015 - Medtronic plc (NYSE: MDT) today
announced the U.S. Food and Drug Administration (FDA) approval of
the CoreValve® System for
valve-in-valve (VIV) procedures in patients whose surgical aortic
heart valves have failed. The CoreValve System is the first
transcatheter heart valve approved in the U.S. for VIV procedures
in both high and extreme risk patients who have limited options or
may otherwise go untreated.
Each year, approximately 200,000 people worldwide
receive surgical aortic valvesi, which
typically last 15 years or more. When a surgical valve degenerates
over time, patients may require another valve replacement. However,
some patients are too sick or frail for a second open-heart
surgery, and the transcatheter VIV procedure may now provide them
with a new treatment option.
During the VIV procedure, the CoreValve System is
placed inside a failing surgical heart valve with an inner diameter
from 17-29 m through a low-profile, 18Fr delivery catheter, which
is approved for use with all four CoreValve sizes (23mm, 26mm, 29mm
and 31mm), as well as three delivery approaches (transfemoral,
subclavian and direct aortic).
The CoreValve system is engineered with a
supra-annular valve design, which helps maximize blood flow for
patients whose artificial heart valves have shown either stenosis,
regurgitation, or both. Outcomes from an Expanded Use Study, an
observational arm of the CoreValve U.S. Pivotal Trial, demonstrated
low rates of mortality and stroke (for a combined rate of 4.2
percent at 30 days and 10.7 percent at 6 months) and significant
improvements in hemodynamics and quality of life in patients with
failed surgical heart valves. Results from the largest global VIV
registry also showed the VIV approach resulted in considerable
hemodynamic (blood flow) improvements, including a decrease in
blood flow resistance. In this registry, positive procedural
outcomes were maintained at one year follow-up with 89 percent
survival, which was comparable with other non-VIV TAVR
studiesii.
"This first-of-its-kind FDA approval showcases
Medtronic's commitment to advancing the TAVR field so that more
patients can receive access to this life-saving, minimally invasive
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. "The CoreValve design is uniquely
suited for valve-in-valve implantation due to its supra-annular
design. We are pleased to be able to provide physicians and
patients with another treatment option to replace surgical heart
valves when needed."
The CoreValve System was approved by the FDA in
2014 for patients at extreme risk and high risk for surgery, and
received CE (Conformité Européenne) Mark for VIV procedures in May
2013. The CoreValve System has been implanted in more than
75,000 patients in more than 65 countries since receiving CE Mark
in 2007. In addition, the CoreValve System offers the broadest
range of sizes available to accommodate more patients.
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 -
i Brown JM et
al; The Journal of Thoracic and Cardiovascular Surgery; V.137;
No.1; 1/09; p82
ii Dvir, D. et
al. "Transcatheter Aortic Valve Replacement for Degenerative
Bioprosthetic Surgical Valves: Results From the Global
Valve-in-Valve Registry." Circulation. October
2012.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Jeff Warren
Investor Relations
+1-763-505-2696
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Source: Medtronic plc via Globenewswire
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