PFM Medical, a developer and manufacturer of minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, has received the US Food and Drug Administration (FDA) premarket approval for its Nit-Occlud patent ductus arteriosus(PDA) occlusion device.
The Nit-Occlud PDA occlusion system is a permanently implanted prosthesis designed for the safe and atraumatic occlusion of the congenital heart defect PDA.
Transcatheter PDA occlusion device is indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter less than 4mm.
Recently, a Phase II clinical study was conducted to assess the safety and effectiveness of the Nit-Occlud PDA.
The study enrolled 378 subjects in 15 study centers throughout the US under an investigational device exemption (IDE).
The FDA approval was based on the favorable results from this clinical study.