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Boston Scientific NC Quantum Apex Balloon Catheter Receives CE Mark, FDA Approval

Boston Scientific has received CE Mark and FDA approval for its NC Quantum Apex PTCA Dilatation Balloon Catheter. The company plans to launch the product in European markets in present week and in the US next month.

The NC Quantum Apex Catheter is the latest from Boston Scientific designed to improve the management of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).

Boston Scientific claimed that the NC Quantum Apex Catheter is a high-performance, post-dilatation balloon catheter developed to address physicians’ needs in optimising coronary stent deployment.

Boston Scientific NC Quantum Apex Catheter 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 is expected to be available worldwide and both the Monorail and Over-the-Wire (OTW) catheter platforms will be available in the US, said the company.

Bruce Brodie, interventional cardiologist at Moses Cone Heart and Vascular Center, chairman of LeBauer Cardiovascular Research Foundation and principal investigator of the POSTIT study, said: “Results from the POSTIT clinical study showed that more than 70% of coronary stents are not optimally deployed by a stent delivery balloon alone.

“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.”

Hank Kucheman, executive vice president and president of Cardiology, Rhythm and Vascular Group at Boston Scientific, said: “As the leader in balloon catheters and drug-eluting stents, Boston Scientific continues to innovate and improve on the products we currently deliver to our physician customers.

“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.”