Natec Medical has received 510k approval from US Food and Drug Administration (FDA) for its Filao NC PTCA balloon catheter, Natec’s third device to obtain FDA approval.
The Filao NC PTCA balloon catheter is a sterile, single-use, rapid exchange percutaneous transluminal coronary angioplasty catheter. 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 Natec’s ProG proprietary hydrophilic coating to provide lubrication.
The 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 post-delivery expansion of balloon expandable stents.
“Having a NC PTCA catheter in a product range is mandatory, because complex lesions (eg. calcific or fibrotic lesions, occurring in small vessels or bifurcations or involve diffused or ostial disease) challenge optimal stent deployment, “says Miroslav Secerov, vice president of sales and marketing. “This is especially pertinent; and the effectiveness of DES has prompted both practitioners and patients to favour stenting over surgery in an increasing number of cases involving complex diseases. In fact, nearly 50% of cardiac lesions treated today are classified as complex, and almost all of them would require and additional stent deployment post dilatation.”