Cardiovascular device firm PFM Medical has the FDA’s green light to market its Nit-Occlud PDA permanent prosthesis in the U.S., according to an approval order posted on FDA’s Website this month.
The device is designed to non-surgically aid in the closure of small-to-moderate sized patent ductus arteriosus, a heart problem in which the ductus arteriosus, which connects 2 major heart arteries before birth to allow fetal blood circulation, fails to close normally. The opening allows oxygen-rich blood from the aorta to mix with oxygen-poor blood from the pulmonary artery, which can strain the heart and increase blood pressure in the lung arteries.
Nit-Occlud is minimally invasive and is implanted percutaneously through a catheter. It is approved for the closure of PTA with a minimum angiographic diameter less than 4 mm, the Cologne, Germany-headquartered firm noted in a press statement.
The FDA did not require PFM Medical’s device to go before its Circulatory Systems Devices advisory, finding that the company’s PMA for Nit-Occlud “substantially duplicates information previously reviewed by this panel." The agency did, however, ask for a newly enrolled, prospective, single-arm, multi-center post-approval trial of patients treated with Nit-Occlud and followed for 5 years post-implant.
In order to meet its primary safety and effectiveness endpoints in the post-approval study, Nit-Occlud must show an adverse event rate of less than 1%, and a greater than 85% 5-year complete closure rate, as assessed by absence of residual flow at 5 years by transthoracic echocardiograph, FDA noted in its summary of safety and effectiveness data for the device.
PFM Medical agreed to enroll 215 patients in the post-approval study to ensure 150 patients treated with the Nit-Occlud PDA will be available at 5 years post-procedure, according to FDA.
The Nit-Occlud PDA has held CE Mark approval in the European Union since 2001 and has been in commercial distribution in Europe, Latin America, Asia and the Middle East. By 2011 nearly 15,000 Nit‐Occlud devices were sold, and the device has never been withdrawn for any safety or effectiveness issues, the FDA noted.
PDA is a “fairly common” congenital heart defect in the U.S., affecting twice as many girls as boys, according to NIH. The condition occurs in about 8 of every 1,000 premature babies and in 2 out of every 1,000 full-term babies.