Boston Scientific has announced that its NC Quantum Apex coronary balloon catheter has received regulatory approval in both US and Europe. The company is releasing the product in Europe this week and in America next month.
From the press release:
The NC Quantum Apex Catheter is a high-performance, post-dilatation balloon catheter developed specifically to address physicians’ needs in optimizing 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 re-designed tip for greater flexibility(1). It is available in a wide array of balloon diameters from 2.0 to 5.0 mm, with balloon lengths ranging from 6 to 30 mm. The Monorail® catheter platform will be available worldwide and both the Monorail and Over-the-Wire (OTW) catheter platforms will be available in the U.S.
Bruce Brodie, M.D., Interventional Cardiologist, Moses Cone Heart and Vascular Center, and Chairman, LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina, and Principal Investigator of the POSTIT study was one of the first physicians in the U.S. to use the NC Quantum Apex Catheter. "Results from the POSTIT clinical study showed that more than 70 percent of coronary stents are not optimally deployed by a stent delivery balloon alone," said Dr. 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."
Press release: Boston Scientific Announces CE Mark and FDA Approval of NC Quantum Apex® Balloon Catheter…