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Medtronic Announces CE Mark Approval of the World’s First Transcatheter Valve Replacement System for Structural Heart Disease


Melody Transcatheter Valve and Ensemble Delivery System is the First Catheter-Based Therapy System Approved for Valve Replacement

MINNEAPOLIS – October 4, 2006 – Signaling a new frontier in the use of transcatheter valve technology, Medtronic, Inc. (NYSE: MDT) announced today that it has received CE Mark approval for its Melody™ Transcatheter Pulmonary Valve and Ensemble™ Transcatheter Delivery System. The system is the first of its kind worldwide to treat congenital patients with structural heart disease requiring pulmonary heart valve replacement.

The Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System is designed to benefit patients with congenital heart defects involving the connection between their right ventricle and pulmonary artery. Oftentimes, this type of defect requires open heart surgery early in life to implant a prosthetic valved-conduit to establish adequate blood flow from the heart to the lungs. However, the functional life span of these conduits is relatively limited, and as a result most patients with this type of defect are committed to multiple open heart surgeries over their lifetime. The Melody valve and Ensemble system provide a non-surgical means to restore effective valve function and prolong the functional life of prosthetic conduits, thereby reducing the number of open heart surgeries for these patients throughout their lifetime.

According to the American Heart Association, congenital heart defects are the No. 1 birth defect worldwide. In the United States alone, more than 25,000 babies are born each year with a congenital heart defect. Approximately 22 percent of these babies born with congenital heart disease have defects disrupting the blood flow from the right ventricle to the pulmonary artery.

“While the population that will benefit from this new technology is relatively small, Medtronic is committed to patient-centered lifetime management of congenital heart disease,” said Oern Stuge, MD, senior vice president and president of the Cardiac Surgery business at Medtronic. “The Melody Valve and Ensemble System are examples of Medtronic’s commitment to evolving the science and focus of structural heart disease. This focus further demonstrates our dedication to delivering innovative valve technology that addresses unmet patient needs. By providing less invasive options for physicians and therefore eliminating even one open heart procedure for a patient, we improve that patient’s quality of life immeasurably.”

Medtronic has partnered with Professor Philipp Bonhoeffer, professor and chief of cardiology and director of the Catheterization Laboratory, Great Ormond Street Hospital for Children (GOSH) in London, and NuMed, a pediatric catheter company in the development of the Melody Valve and Ensemble System. A pioneer in transcatheter valve technology, Professor Bonhoeffer implanted the world’s first transcatheter valve in September 2000. To date, more than 150 patients worldwide have been implanted with the Melody Transcatheter Pulmonary Valve.

Transcatheter valve technology represents a less invasive means to treat heart valve disease and is designed to allow physicians to deliver replacement valves via a catheter through the body’s cardiovascular system, thus eliminating the need to open the chest. Traditionally, open heart surgery has been required to correct the problem and it is not unusual for a patient to undergo multiple, open-heart surgeries during their lifetime. Patients with this condition tire very easily, as the heart over-exerts itself trying to get oxygenated blood throughout the body.

“To reopen the chest many times is obviously uncomfortable for the patient but also comes with risk. By using the Melody Valve and Ensemble System, we can now avoid the open chest procedure and instead perform the same procedure safely, quickly, and more comfortably,” said Professor Bonhoeffer.

CE Mark Approval gives Medtronic the ability to train and educate physicians in Europe in preparation for implanting the Melody™ and Ensemble™ System so that more patients can benefit from this innovative treatment. With proper training in place, Medtronic will work with hospitals across Europe in gaining access to this new technology.

While the Melody Valve and Ensemble System are not currently available in the United States, Medtronic is working with the United States Food and Drug Administration to pursue plans to apply this new approach in transcatheter valve therapy for patients in the U.S.

About Medtronic
Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Editor’s Note:
Physicians are available for interviews to discuss experience with the Melody Valve and Ensemble System in Canada and the U.K. Broadcast quality animation is also available. Information about the product and treatment is available at ( Contact Angela Pennington at 303.399.4109 to arrange interviews or request footage.


Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 30, 2006. Actual results may differ materially from anticipated results.


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