FDA Panel Recommends Approval of Medtronic Heart Valve under Humanitarian Device Exemption
July 23, 2009 – The FDA’s Circulatory System Devices Panel today recommended (12-0) conditional approval of a humanitarian device exemption (HDE) for Medtronic’s Melody Transcatheter Pulmonary Valve, for the treatment of children and adults with congenital heart disease.
The FDA usually follows the recommendations of its expert panels. Devices approved under HDE are intended to serve patient populations of fewer than 4,000 per year in the United States.
“This Melody valve is an enormous breakthrough – and an enormous relief – for patients with congenital heart disease,” said pediatric cardiologist William E. Hellenbrand, M.D., of the NewYork-Presbyterian Morgan Stanley Children's Hospital and professor of clinical medicine at Columbia University Medical Center. “The device offers the potential to break the cycle of open-heart surgery after open-heart surgery. If the FDA follows the advice of its expert panel, physicians and patients will have a powerful new option for these very sick and hard-to-treat patients.”
Transcatheter valve (TCV) technology provides a less invasive means to replace a failing heart valve. It is designed to allow physicians to deliver replacement valves via a catheter through the body’s cardiovascular system, eliminating the need to open the chest. TCV technology can thereby delay open-heart surgery for valve replacement. Medtronic is developing TCVs for all four valves of the heart: aortic, mitral, pulmonic and tricuspid.
The Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to be approved for commercial use anywhere in the world and the first to be reviewed by an FDA panel. It received Conformité Européenne (CE) mark, the European regulatory approval, in October 2006, and has been approved for sale in Canada since December 2006. To date, nearly 1,000 patients worldwide have benefited from the Melody Transcatheter Pulmonary Valve. With today’s panel recommendation, the device is on track to become the first transcatheter heart valve of any kind to receive FDA approval for use in the United States.
The panel’s recommended conditions of approval include a post-approval study, revision of the patient brochure and instructions for use, and implementation of a physician training and education program.
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.
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.
For more information: www.medtronic.com