FDA Approves NATEC Medical's Filao NC PTCA Balloon Catheter

July 29, 2015—NATEC Medical Ltd announced that it received 510(k) approval from US Food and Drug Administration for its Filao NC percutaneous transluminal coronary angioplasty (PTCA) balloon catheter. The Filao NC is a sterile, single-use, rapid exchange device. The Filao NC PTCA balloon catheter is indicated for balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis to improve myocardial perfusion as well as the postdelivery expansion of balloon-expandable stents.

According to the company, the balloon is designed to provide an accurate working length and predictable diameter under high pressures. Two radiopaque markers aid in positioning the balloon catheter under fluoroscopy during the procedure. The distal portion of the shaft is coated with the company’s ProG hydrophilic coating to provide lubrication.

NATEC Medical, which is based in Mauritius, is a privately held manufacturer and distributor of PTCA and percutaneous transluminal angioplasty balloon catheters.