Medtronic Clinical Trial Receives FDA Approval to Evaluate New CoreValve® System for Aortic Valve Implantation
Investigational Transcatheter Aortic
Valve Implantation System Part of Medtronic’s Growing Portfolio for
U.S. Patients with Severe Aortic Stenosis
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October 15, 2010 -- Minneapolis --
Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug
Administration (FDA) conditional approval for its Investigational
Device Exemption (IDE) application and pivotal clinical trial
protocol to begin evaluating the Medtronic CoreValve System for
transcatheter aortic valve implantation (TAVI). The CoreValve
System is designed to provide a minimally invasive, non-surgical
treatment option for patients with symptomatic, severe aortic
stenosis who are at high risk, or are ineligible, for 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 surgery,1 the only
therapy with significant clinical effect that is currently available
in the United States. The Medtronic CoreValve System will soon
be under investigational use and is not yet commercially available
in the U.S.
“There is a distinct need for
a new treatment option for many older patients with a severely
diseased aortic heart valve and, as the population ages, this
need continues to grow,” said Jeffrey Popma, M.D., Medtronic
CoreValve U.S. Pivotal Trial co-principal investigator based
at Beth Israel Deaconess Medical Center in Boston.
The CoreValve
System is designed with self-expandable technology to replace
a diseased aortic valve percutaneously, usually through the femoral
artery, without open-heart surgery or surgical removal of the
native valve. Since receipt of CE (Conformité Européenne) Mark
in March 2007, the system has been implanted in more than 12,000
patients worldwide in more than 34 countries outside the U.S. |
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Jeffrey
Popma, MD |
“This study represents a significant opportunity to fundamentally change the way we treat Americans with severe aortic stenosis,” said David H. Adams, M.D., professor and chairman of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center in New York City and co-principal investigator of the CoreValve trial. “Cardiologists
and cardiac surgeons will collaborate more closely than
ever before to carefully select and deliver this innovative
therapy.” About Symptomatic Severe Aortic Valve Stenosis
Aortic stenosis is a condition of the aortic valve which prevents the valve from opening completely, thereby preventing healthy blood flow from the aorta to the rest of the body. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood and sometimes causes a back-up of blood into the lungs. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. About the CoreValve IDE Pivotal Trial
The Medtronic CoreValve System with the AccuTrak™ stability layer
will be investigated in two independent studies. Together the two
studies will enroll more than 1,200 patients at 40 U.S. clinical
sites; the sites will be identified on www.clinicaltrials.gov when
they begin enrolling patients. The studies will evaluate the treatment’s
safety and efficacy in two groups of patients with severe aortic
stenosis: those who have been diagnosed as high risk for aortic
valve surgery, and those who have been deemed at extreme risk for
aortic valve surgery (i.e. inoperable). Patients who are considered at high surgical risk will be randomized one-to-one to either transcatheter aortic valve implantation (TAVI) with CoreValve or to surgical aortic valve replacement (SAVR). The primary endpoint for this trial is freedom from all-cause mortality at 12 months. Study participants deemed at extreme risk for surgical valve replacement will be randomized two-to-one to receive either TAVI with CoreValve or optimal medical management. This trial has co-primary endpoints: all-cause death or major stroke occurring within a minimum of 12 months of follow-up; and a composite of all-cause death, major stroke, days of hospitalization for aortic valve disease, and number of hospitalizations for aortic valve disease occurring within a minimum of 12 months of follow-up. “FDA approval of this groundbreaking clinical trial is a critical step toward a U.S. introduction of CoreValve,” said John Liddicoat, M.D., vice president and general manager of the Structural Heart division at Medtronic. “Medtronic
is the only company with the deep technical, clinical and market
expertise in both catheter-delivered therapies and heart valves,
and is singularly poised to provide physicians and patients
a broad portfolio of transcatheter heart valve therapies.” 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 Medtronic’s periodic reports
on file with the Securities and Exchange Commission.
1 Iung
B, Cachier A, Baron G, et al. Decision-making in elderly
patients with severe aortic stenosis: why are so many
denied surgery? Eur Heart J. 2003;26:2714-2720.
Source: Medtronic,
Inc.
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