2013-05-23 09:03:04 -
Replacing Degenerated Surgical Valves with CoreValve Results in
Significant Hemodynamic Improvements for Patients
MINNEAPOLIS - May 23, 2013 - Medtronic, Inc. (NYSE: MDT) today announced it has
received Conformité Européenne (CE) Mark for valve-in-valve (VIV) procedures
using the CoreValve® and CoreValve® Evolut(TM) transcatheter aortic valve
implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves.
This is the first ever regulatory approval for VIV procedures, which provide a
minimally invasive treatment option for patients whose surgical aortic valves
have degenerated, and who are at extreme or high risk for surgery and would
otherwise go untreated. The CoreValve VIV procedures are not approved in the
Results from the largest global VIV registry, published in Circulation in
(Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic
Surgical Valves: Results from the Global Valve-in-Valve Registry), showed the
VIV approach resulted in considerable hemodynamic (blood flow) improvements,
including a decrease in valve gradients (blood flow resistance). Positive
procedural outcomes were maintained at 1-year follow-up (with 89 percent
survival at one year), which was comparable with other non-VIV TAVI studies.(1)
"While surgical valves provide effective therapy for many patients, the
replacement valves eventually degenerate over time, so valve-in-valve has become
a topic of great clinical interest due to the needs of these patients," said Ran
Kornowski, M.D., chair of cardiology at Rabin Medical Center and Tel-Aviv
University in Tel-Aviv, Israel, and previously at Washington Hospital Center in
Washington, D.C., and senior author of the Global Valve-in-Valve Registry.
"European approval of the CoreValve procedure is a very important advance in the
treatment of severe aortic stenosis and enables an entirely new group of
patients to benefit from this transcatheter valve."
The Global VIV registry evaluated the safety and efficacy of the VIV approach in
202 patients at 38 sites in Europe, North America, Australia, New Zealand and
the Middle East,(1) with 124 patients receiving the CoreValve System. In the
study, the CoreValve System demonstrated superior hemodynamic outcomes and high
procedural success rates (96.8 percent).(1)
The valve-in-valve procedure, in which the CoreValve System is placed inside the
degenerated surgical aortic valve through a low-profile, 18Fr delivery catheter,
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
"We are pleased to now extend this safe and less-invasive, valve-in-valve
procedure. This approach allows patients to avoid a second open-heart surgery to
replace a failing surgical valve, which was originally performed to replace
their own diseased valve." said John Liddicoat, M.D., senior vice president,
Medtronic, and president of the Medtronic Structural Heart Business.
"Furthermore, the impressive improvements in hemodynamic performance, due to
CoreValve's supra-annular design, are showcased in the results of these valve-
Each year, approximately 200,000 people worldwide receive surgical aortic
valves,(2) which typically last 15 years or more. When the surgical valves
degenerate due to the aging process, patients require another valve replacement.
However, some patients are not eligible for a second open-heart surgery, and the
transcatheter VIV procedure now may provide them with a new treatment option.
The Medtronic CoreValve System is available in the United States for
investigational use only. In the Medtronic CoreValve U.S. Expanded Use Study,
the U.S. Food and Drug Administration has approved investigational VIV
procedures in extreme-risk patients (part of the pivotal trial evaluating the
CoreValve System in the U.S.).
In collaboration with leading clinicians, researchers and scientists, 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 worldwide.
To view the hi-res image of the Medtronic CoreValve® Evolut(TM) in a surgical
bioprosthetic valve ("valve-in-valve"), click here.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, 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
(1) Dvir, D. et al. "Transcatheter Aortic Valve Replacement for Degenerative
Bioprosthetic Surgical Valves: Results From the Global Valve-in-Valve Registry."
Circulation. October 2012
(2) Brown JM et al; The Journal of Thoracic and Cardiovascular Surger; V.137;
No.1; 1/09; p82
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Source: Medtronic, Inc. via Thomson Reuters ONE