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The Methodist Hospital chosen for percutaneous valve replacement study

Houston, TX - 1/24/2011

The Methodist DeBakey Heart & Vascular Center was chosen today as a site for a critical percutaneous heart valve study. As part of the research study, Methodist physicians will replace diseased cardiac valves through a single, tiny puncture hole in the research subject's groin.

"Using this new technique in the study, we will be able to replace severely calcified and damaged aortic valves without open heart surgery or removal of the original diseased valve," said Dr. Neal Kleiman, director of the catheterization labs at the Methodist DeBakey Heart & Vascular Center and cardiology principal investigator for the trial. "This study is the only way individuals have access to this technique in the United States."

The Medtronic CoreValve® System, which is delivered into the individual's heart via catheter, has been implanted in more than 12,000 patients worldwide and is available in 34 countries outside the United States.

The trial incorporates expertise of both cardiac surgeons and cardiologists. Using this technique, physicians make a tiny puncture hole in the individual's groin and thread a catheter through the femoral artery into the heart. The valve is delivered to the site of the diseased aortic valve through the catheter, then the new valve is deployed inside the individual's original valve, thus providing the individual with a functioning valve to allow for effective blood flow.

"We routinely perform surgical valve replacement for diseased aortic valves, but many individuals are too high a risk for open-heart surgery due to age or other illness, said Dr. Michael Reardon, cardiac surgeon at Methodist and surgical principal investigator for the trial. "In this trial, we will evaluate whether catheter based aortic valve replacement will help extend the lives of this group of individuals."

The aorta is the main artery that carries blood from the heart to the body's vital organs. Blood flows through the aortic valve when it leaves the heart. Aortic stenosis is a narrowing of the aortic valve that prevents the valve from opening fully. This narrowing restricts blood flow and causes fatigue, chest pain, light headedness, palpitations and weakening of the heart over time. When the valve becomes too damaged to be treated with medications, it needs to be replaced.

Worldwide, approximately 300,000 people have been diagnosed with this condition (100,000 in the U.S.), 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.

Traditionally, a valve is replaced with a tissue or mechanical valve during open-heart surgery, which requires a surgical incision and a one month recovery period. Transcatheter valve replacement is being studied in part to evaluate recovery times and exposure to side affects of major surgery.

In July, Methodist opened a new hybrid robotic operating suite that integrates advanced robotics, imaging and navigation with surgery to offer patients the least invasive and safest surgical and interventional treatments for cardiovascular disease.

"The new suite is perfectly designed for advanced procedures like the percutaneous valve," said Dr. Alan Lumsden, medical director of the Methodist DeBakey Heart & Vascular Center in Houston. "The clear 3D imaging we have in this new room enables us to maneuver the valve into place and position it much more accurately and precisely than ever before. This is vitally important in such an advanced technique."

Methodist will be one of 40 sites in the country studying this new technique. The study investigators are currently screening subjects for enrollment. Methodist will enroll approximately 100 patients over the course of the trial. The Medtronic CoreValve U.S. Pivotal Clinical Trial will enroll a total of more than 1,300 patients in the United States. Outside the U.S., CoreValve received CE (Conformité Européenne) Mark in Europe in 2007.

[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.

To learn more about enrollment in the Medtronic CoreValve® U.S. Pivotal Trial at the Methodist DeBakey Heart & Vascular Center, please contact Nicole Hakala, Study Coordinator, at 713-441-6539 or 281-615-9407, or send an email to nhakala@tmhs.org.

The Methodist DeBakey Heart & Vascular Center

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