Boston Scientific Corporation (NYSE: BSX) today announced CE Mark and U.S. Food and Drug Administration (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 U.S. next month.
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. 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.
Jean Fajadet, M.D., 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 Dr. Fajadet. "It features an innovative design and impressive performance that should benefit interventional cardiologists and their patients."
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."
"As the leader in balloon catheters and drug-eluting stents, Boston Scientific continues to innovate and improve on the best-in-class products we currently deliver to our physician customers," said Hank Kucheman, Executive Vice President and President of Boston Scientific's Cardiology, Rhythm and Vascular Group. "The next-generation NC Quantum Apex Catheter is another example of our leadership, offering improved performance over the industry standard Quantum™ Maverick® and providing enhanced treatment options for our physicians and their patients."
PTCA dilatation catheters are used in coronary angioplasty and stenting procedures to open arteries blocked by atherosclerosis, which if left untreated can cause heart attack and stroke. Coronary artery disease represents the leading cause of death in the United States and Europe, accounting for more than 870,000 U.S. deaths each year and 1.95 million deaths annually in Europe.
The NC Quantum Apex Catheter is the latest innovation from Boston Scientific designed to improve the management of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). Boston Scientific offers a broad range of devices intended to optimize PCI procedures, including ultrasound imaging to assess lesions, and balloon catheters and drug-eluting stents to reopen blocked arteries. This comprehensive portfolio supports physicians' efforts to achieve safe and effective outcomes for their patients.
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