FDA approval and CE mark for Boston's new balloon catheter
This article was originally published in Clinica
The US FDA has granted premarket approval (PMA) for Boston Scientific's NC Quantum Apex balloon catheter. The Natick, Massachusetts firm has also CE marked the product for sale in Europe, where it plans to launch it this week. US launch is slated to follow next month. The "next-generation" balloon catheter is designed for patients with coronary artery disease undergoing percutaneous coronary intervention, helping to optimise coronary stent deployment by opening arteries blocked by atherosclerosis. The catheter features a new Bi-Segment inner shaft for "improved trackability" and a re-designed tip for greater flexibility, Boston says. It is available in diameters of 2-5mm, and lengths of 6-30mm.