Boston Scientific's NC Quantum Apex Balloon Catheter Approved

May 25, 2010—Boston Scientific Corporation (Natick, MA) announced CE Mark approval and US Food and Drug Administration (FDA) approval of the NC Quantum Apex percutaneous transluminal coronary angioplasty (PTCA) dilatation balloon catheter. The company plans to launch the product in European markets during the last week of May and in the United States in June.

The NC Quantum Apex is a postdilatation balloon catheter designed for coronary stent deployment. The device incorporates the company's new Bi-Segment inner shaft for improved trackability and a redesigned tip for greater flexibility. It is available in balloon diameters from 2 to 5 mm and balloon lengths from 6 to 30 mm. The monorail catheter platform will be available worldwide, and both the monorail and over-the-wire catheter platforms will be available in the United States.

“Results from the POSTIT clinical study showed that more than 70% of coronary stents are not optimally deployed by a stent delivery balloon alone,” commented Bruce Brodie, MD, the study's principal investigator. “The use of intravascular ultrasound with an adjunctive postdilatation balloon makes it twice as likely that a stent will be optimally deployed.”