Patients with a dysfunctional pulmonary valve tire easily, as the heart over-exerts itself trying to get oxygenated blood throughout the body. The condition has traditionally required opening the chest for heart surgery, which is associated with discomfort and significant risks for the patient.

The Melody Transcatheter Pulmonary Valve gives physicians and patients the option to delay the next open-heart surgery. The device is intended to ensure blood flow from the right ventricle to the lungs, and ultimately to the rest of the body. The Melody system may also reduce the cost of treatment by avoiding surgical complications, postoperative intensive care and extended hospital stays.


"We are very pleased with the FDA panel's recommendation today and look forward to working with the FDA to address labeling and any remaining issues as quickly as possible so that more congenital heart disease patients in the United States can benefit from this technology," said cardiac surgeon Dr. John Liddicoat, vice president and general manager of the Structural Heart division, part of the CardioVascular business at Medtronic. "By providing a less invasive option and therefore delaying even one open-heart surgery, we can improve the lives of thousands of congenital heart disease patients."

Following today's panel recommendation, the Melody Transcatheter Pulmonary Valve remains an investigational device in the United States, where its use is limited to a clinical trial approved by the FDA. Approval of the Melody system as an HDE is under review by the FDA.

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.


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