FDA reviewers said that Medtronic’s Melody heart valve device met safety and effectiveness goals in a study of patients born with heart defects. FDA staff stated that they would ask an advisory panel about fractures found in a part of the Melody heart valve device in some patients.
The Melody heart valve device is a novel type of valve implanted through less invasive means and does not require open-heart surgery. The valve is intended for patients born with heart defects which disrupt blood flow from the right ventricle to the pulmonary artery and the valve can be implanted by threading a tube through a leg vein to the heart.
A panel outside experts will review data and make recommendations about whether the device should be approved or not. The FDA usually follows panel advice.
FDA reviewers stated that the device met key goals in the company study which measured rates of successful implantation, death and serious complications but staff also stated that they would ask the panel about the significance of fractures seen in tiny mesh tubes known as stents which are used in delivery of the valve.
A Medtronic study in US patients found an 18 percent stent fracture rate and five of 16 patients with the fractures required a repeat procedure stated FDA reviewers.
Medtronic released a separate summary by the FDA which stated that the device was intended for a small group of patients, many of them young, who have previously undergone open-heart surgery and likely will need it repeated.
The company also stated that the use of the Melody device may delay or prevent future surgeries, reducing the number of open-heart operations over a lifetime.
Data provide strong evidence the Melody system provides a probable benefit to health that outweighs the risk of injury or illness from its use, the company said.
The company is seeking approval under an exemption which allows devices to be used in up to 4,000 patients per year if the manufacturers demonstrate a probable benefit without unreasonable risk of harm. The Melody valve already is approved in Europe and Canada.