Boston Scientific announces CE mark and FDA approval of NC Quantum Apex Balloon Catheter


Boston Scientific announced on 25 May 2010 CE mark and FDA approval of its NC Quantum Apex PTCA Dilatation Balloon Catheter. The Company plans to launch the product in European markets this week and in the US next month.  

The NC Quantum Apex Catheter is a high-performance, post-dilatation balloon catheter developed specifically to address physicians’ needs in optimising coronary stent deployment. It represents the next generation of balloon catheter technology, and is designed to deliver enhanced performance through the use of a new Bi-Segment Inner Shaft for improved trackability and a redesigned tip for greater flexibility. It is available in a wide array of balloon diameters from 2 to 5mm, with balloon lengths ranging from 6 to 30mm. The Monorail catheter platform will be available worldwide and both the Monorail and Over-the-Wire (OTW) catheter platforms will be available in the USA.

Jean Fajadet, director of the Interventional Cardiology Unit, Clinique Pasteur, Toulouse, France, was the first physician to treat patients with the new balloon catheter. “The NC Quantum Apex Catheter performed very well, offering a noticeably lower profile, excellent trackability and effective post-dilatation,” said Fajadet. “It features an innovative design and impressive performance that should benefit interventional cardiologists and their patients.”

Bruce Brodie, interventional cardiologist, Moses Cone Heart and Vascular Center, and Chairman, LeBauer Cardiovascular Research Foundation, Greensboro, USA, and principal investigator of the POSTIT study was one of the first physicians in the US to use the NC Quantum Apex Catheter. “Results from the POSTIT clinical study showed that more than 70% of coronary stents are not optimally deployed by a stent delivery balloon alone,” said Brodie. “The use of IVUS with an adjunctive post-dilatation balloon makes it twice as likely that a stent will be optimally deployed. The NC Quantum Apex Catheter is a great addition to the available post-dilatation balloons, making it easier for physicians to achieve optimal stent deployment.”