WASHINGTON -- The FDA has approved the Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve designed for implantation through a catheter in a leg vein.
The device gives congenital heart defect patients with poorly functioning pulmonary valve conduits new treatment options without requiring open heart surgery.
The valve does not cure the condition and may wear to the point of needing replacement over time, but a tissue valve in the device maintains proper blood flow-direction, which allows the valve to function longer than usual, an FDA statement said.
Approval was based on clinical studies of 99 U.S. patients and 68 European patients.
Participants showed improved heart function, and a majority noted improvements in clinical symptoms, the statement said.
The limited durability of the device was similar to other existing treatments in the trial, with 21% of U.S. patients experiencing a stent fracture, the release said.
Device manufacturer Medtronic must complete two postapproval studies to test long-term risks and benefits, including one study with 150 participants from the original clinical trials and more than 100 additional patients, who will each undergo a five-year evaluation.
An additional condition of the device's approval is a review of healthcare professional specialization required for device implantation. The manufacturer must also maintain a database of valve recipients.
The transcatheter valve was approved under the Humanitarian Device Exception (HDE) program, which supports device development for conditions affecting fewer than 4,000 people and allows approval for limited use with reasonable assurances that the device health benefit outweighs risk of injury or illness.
Products with HDE approval can only be used at medical institutions under an institutional review board and cannot be sold for more than the cost of research, development, fabrication, and distribution.