FDA Okays Valve That Can Be Placed Without Open-Heart Surgery

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES -JANUARY 25, 2010,
WASHINGTON (Dow Jones)--The Food and Drug Administration Monday approved a Medtronic Inc. (MDT) heart valve that can be implanted without open-heart surgery.
The device, known as the Melody transcatheter pulmonary valve, is designed to be implanted into patients through a small catheter that's inserted into the body. It replaces the pulmonary valve in patients born with a heart defect, and is the first heart valve approved for sale in the U.S. that be implanted without open-heart surgery.
"The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition," said Jeffrey Shuren, the director of FDA's devices division. The valve won't cure a patient's heart condition and over time will likely need to be replaced.
The Melody was approved under the FDA's Humanitarian Device Exemption program which allows devices to be approved for use to treat medical conditions that affect 4,000 or fewer patients in the U.S. annually.
FDA's approval of the Melody valve follows the July recommendation of an outside panel of medical experts which said the device had "probable benefit."
Medtronic officials have said the pulmonary value would likely be implanted in fewer than 1,000 U.S. patients annually. However, the potential market for other replacement heart valves such as the aortic valve that could be replaced without major surgery is much larger.
Medtronic acquired a company last year that sells an aortic value replacement system in Europe and plans to eventually seek FDA approval of the product in the U.S. Edwards Lifesciences Corp. (EW) also sells transcatheter heart valves in Europe and also plans to seek FDA approval to sell its valves in the U.S. The company hopes to win approval for the valves next year.
Medtronic's pulmonary valve was studied in a small group of patients who were born with a heart defect that disrupts the blood flow from the heart's right ventricle to the pulmonary artery that leads to the lungs. Patients with such heart defects typically require several open-heart surgeries to replace heart valves. The Melody valve could delay the need for open-heart surgery and cut the number of surgeries, but is unlikely to completely eliminate the need for open-heart surgery.
The FDA said clinical studies of 99 patients in the U.S. and 68 patients in Europe showed that the device improved function of the heart and the majority of participants have noted improvements in their clinical symptoms.
The agency said the device showed similar, limited durability compared with existing alternative treatments with 21% of U.S. patients experienced a stent fracture. The rate is similar to the number of stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve. The concern about stent fractures is that parts of the device could break off and result in blood clots.
However, the FDA said during the July advisory panel meeting, that devices which were removed from patients showed that stent fragments were incorporated into the vein wall, meaning there's a "low probability" that such fragments would cause blood clots.
The FDA said Medtronic will be required to conduct two post-approval studies to assess long-term risks and benefits of the product. The company will also be required to assess a physician training program and to maintain a database of Melody recipients.