pfm medical (Köln, Germany) has received FDA approval for the Nit-Occlud PDA, a percutaneous closure device specifically designed to occlude patent ductus arteriosus heart defect (PDA).
The Nit-Occlud is delivered percutaneously, and can be repositioned as needed before final deployment. It’s nitinol coil spiral is comprised of an outer coil wire wound around an inner coil. The coil self-expands when unsheathed, plugging the gap and preventing the blood from mixing. Tissue growth over the implant will eventually allow it to become part of the pulmonary artery. There are two primary benefits to Nit-Occlud PDA. First, the coil occluder has a stiffness gradient, increasing from the pulmonary to aortal side, allowing the coil to conform to uniquely varying anatomy. Second, the spiral shape of the coil also ensures the occluder can be implanted accurately and easily.
Nit-Occlud was first CE-marked in 2001, and has since sold over 15,000 devices across the world. Multiple sizes allow physicians more flexibility in treating patients with differing types and sizes of PDA, up to 6 mm in diameter.
From the company’s announcement:
Nit-Occlud® PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter less than 4 mm.
A Phase II Clinical Study was conducted with 378 subjects enrolled in 15 study centers throughout the U.S. under an Investigational Device Exemption (IDE) to establish a reasonable assurance of safety and effectiveness of the Nit-Occlud® PDA. Favorable results meeting all objective performance criteria from this clinical study were the basis for the premarket approval decision.
Product page: Nit-Occlud PDA occlusion system…