FDA PMA approval for Boston's Apex PCTA dilatation catheter
This article was originally published in Clinica
Executive Summary
Boston Scientific's Apex PCTA (percutaneous transluminal coronary angioplasty) dilatation catheter has received premarket approval (PMA) from the US FDA. It is designed for use during angioplasty and stenting procedures to open arteries blocked by complex atherosclerotic lesions, and is available on the Natick, Massachusetts firm's Monorail and Over-The-Wire catheter platforms. The catheter has a Bi-Segment inner shaft for "improved pushability and flexibility", Boston says. Balloon diameters of 1.5-5mm are available, with balloon lengths of 8-40mm (depending on diameter). There are two different 1.5mm designs – the Apex Push and Apex Flex catheters, the former for tight lesions and the latter for tortuous lesions. Boston CE marked the catheter for sale in Europe in October 2007 (see Clinica No 1276, p 18).