The FDA’s Circulatory System Devices Panel has unanimously recommended Humanitarian Device Exemption (HDE) approval of Medtronic‘s Melody Transcatheter Pulmonary Valve. For now, the device is designed for patients with congenital heart defects, status post open heart surgery, who developed right ventricular outflow tract (RVOT) obstruction.
From Medtronic announcement:
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.
Press release: FDA Panel Recommends Approval of Medtronic Heart Valve Under Humanitarian Device Exemption…
Product page: Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System…
Flashbacks: Melody™ Transcatheter Pulmonary Valve Still Being Tested in the US; The Melody Transcatheter Pulmonary Valve; The Melody Valve Approved in Canada