FDA Approves PFM Medical Heart Device

PFM Medical, which makes minimally invasive devices for cardiovascular technology, vascular access, surgery, and oncology, has earned premarket approval from the U.S. Food and Drug Administration for its Nit-Occlud PDA (patent ductus arteriosus) device. Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size PDA with a minimum angiographic diameter less than 4 mm.

Patent ductus arteriosus is a condition where the ductus arteriosus, the blood vessel connecting the pulmonary artery to the proximal descending aorta, fails to close after birth. The condition can lead to congestive heart failure.

A phase II clinical study was conducted with 378 subjects enrolled in 15 study centers throughout the United States under an investigational device exemption to establish a reasonable assurance of safety and effectiveness for the device. Favorable results meeting all objective performance criteria from this clinical study were the basis for the premarket approval decision.

PFM Medical is headquartered in Cologne, Germany, with U.S. offices in Carlsbad, Calif.