MINNEAPOLIS–(BUSINESS WIRE)–Medtronic, Inc. (NYSE:
MDT) today announced it has received CE (Conformité Européenne) Mark for the
Medtronic CoreValve® System to be delivered using direct aortic access. The
Medtronic CoreValve System is now the only transcatheter aortic valve
implantation (TAVI) system approved for direct aortic and subclavian
implantation. The Medtronic CoreValve System is currently limited to
investigational use in the United
States.
“For patients at high risk for surgery, transcatheter aortic
valve implantation has become an established alternative for aortic valve
replacement, yet we have found that some patients are considered unsuitable
because of small vessel size,” said Giuseppe Bruschi, M.D., cardiac surgeon at
A De Gasperis Cardiology & Cardiac Surgery Department, Niguarda Ca Granda
Hospital, Milan, Italy. “For these patients, the direct aortic approach
provides a minimally-invasive surgical option.”
This new approach will provide severe aortic stenosis
patients with a viable treatment alternative to the transfemoral (in the upper
leg), transapical (through the wall of the heart), and subclavian artery
(beneath the collar bone) approaches used by TAVI practitioners. In the
procedure, physicians replace the diseased valve through a minimally invasive
incision without stopping the heart or penetrating the hearts ventricular
wall. Early evaluations have shown the direct aortic approach demonstrates high
procedural success rates and high overall survival rates that are similar to
those from transfemoral and subclavian approaches. The new approach also may
allow for easier manipulation and positioning of the valve due to the short
distance from access site to implantation site.
“The direct aortic approach gives heart teams a new,
minimally-invasive option as they seek to customize care for their patients,”
said John Liddicoat, senior vice president of Medtronic and president of the
Medtronic Structural Heart Business. “The CoreValve System is now available in
three sizes (26mm, 29mm and 31mm) via three access routes, all based on the
Systems original self-expanding platform that received CE Mark in 2007.”
The CoreValve System is designed to replace diseased aortic
valves without open-heart surgery. Worldwide, approximately 300,000 people have
been diagnosed with this condition, and approximately one-third of these
patients are deemed at too high a risk for open-heart surgery1. Since 2007, the
Medtronic CoreValve System has been implanted in more than 20,000 people in
more than 50 countries.
About Medtronic
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 Medtronics periodic reports on file
with the Securities and Exchange Commission. Actual results may differ
materially from anticipated results.
1 Decision-making in elderly patients with severe aortic
stenosis: why are so many denied surgery? Bernard Iung et al. Eur Heart
J (December 2005) 26(24): 2714-2720.
