Medtronic Announces Canadian Market Release Of The 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 in North America
MINNEAPOLIS – January 10, 2007 – Medtronic, Inc. (NYSE:MDT) announced today it has received a Medical Device License from Health Canada to sell its Melody™ Transcatheter Pulmonary Valve and Ensemble™ Transcatheter Delivery System.* The system is the first of its kind in North America to treat patients with congenital and acquired structural heart disease requiring pulmonary valve replacement.
“This approval marks another significant milestone for this unique transcatheter valve replacement system,” said Oern Stuge, MD, senior vice president and president of the Cardiac Surgery business at Medtronic. “Quite simply, this system is designed to reduce the number of times that certain patients may need to undergo open heart surgery by providing a minimally invasive, catheter-based solution to valve replacement. Medtronic remains committed to our pioneering work in structural heart disease, and we are pleased that patients in Canada will now be able to benefit from this less invasive approach to valve replacement.”
The Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System are 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 Canada, congenital heart defects occur in one out of every 100 babies born each year and more than 20 percent of these defects involve the pulmonary valve.
To date, more than 190 patients worldwide have been implanted with the Melody Transcatheter Pulmonary Valve. In Canada, Dr. Lee Benson, an interventional cardiologist at the Hospital for Sick Children in Toronto and Dr. Eric Horlick, at the University Health Network, Toronto General Hospital, Toronto were the first in North America to implant Melody Valves under special access permission from Health Canada in October 2005.
The Melody Valve and Ensemble System received CE Mark approval for use in certain markets outside the United States in September 2006. The Melody Valve and Ensemble System are not currently available in the United States. Medtronic is working with the U.S. Food and Drug Administration to pursue plans to apply this new approach in transcatheter valve therapy for patients in the United States.
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.
*Medtronic B.V., a wholly owned subsidiary of Medtronic, Inc., received CE Mark on the Melody Valve and Ensemble System September 2006.
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 28, 2006. Actual results may differ materially from anticipated results.
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