MINNEAPOLIS–(BUSINESS WIRE)–Medtronic, Inc. today announced it has completed patient enrollment in the extreme risk
study in its CoreValve U.S. Pivotal Trial. The company also received approval
from the U.S. Food and Drug Administration (FDA) for an extended investigation (under
the FDAs Continued Access Policy) to continue enrolling extreme risk patients
under a Continued Access Study protocol. In the Trials second study
evaluating high risk patients for aortic valve surgery, enrollment completion
is anticipated later this year.
The CoreValve U.S. Trial is evaluating the self-expanding
CoreValve System in three sizes (26mm, 29mm and 31mm) and using three delivery
access routes: through the transfemoral artery in the upper leg, through the
subclavian artery beneath the collar bone, and directly through the aorta via a
commonly-used, minimally invasive surgical incision that does not penetrate the
hearts ventricular wall.
“The CoreValve Trial investigators are very encouraged by
our experience using the investigative CoreValve system to treat patients with
severe aortic stenosis, and we are eager to fulfill the requirements of the
Trial in hopes of offering the valve to more patients in the future,” said
David H. Adams, M.D., chair of the Department of Cardiothoracic Surgery at The
Mount Sinai Medical Center and national co-principal investigator of the
CoreValve U.S. clinical trial. “With its varying sizes and vascular access
routes, the CoreValve System provides flexibility that we hope will accommodate
most patients anatomical circumstances.”
Overall, the trial is enrolling more than 1,500 patients in
clinical sites, with approximately two-thirds of patients in the high risk
study. Patients in the extreme risk study are being evaluated against a
performance goal derived from contemporary studies. Patients in the high risk
group are being randomized one-to-one to either transcatheter aortic valve
implantation with the CoreValve System, or to surgical aortic valve
“Medtronic is very pleased with our investigators
enrollment progress and with the clinical communitys enthusiasm for the
CoreValve U.S. Trial,” said John Liddicoat, M.D., senior vice president,
Medtronic, and president of the Medtronic Structural Heart Business.
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 25,000 people in
more than 50 countries outside the U.S.
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.
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.
Posted by Sean Fenske, Editor-in-Chief, MDT