Guidant's coronary dilation catheter cleared by FDA:
This article was originally published in Clinica
Executive Summary
Guidant has clearance from the FDA to market its ACS Tx2000 VP coronary dilation catheter in the US. The catheter, manufactured by Guidant's Vascular Intervention Group, is a 0.014 over-the-wire catheter with a rated burst pressure of 18 atmospheres. Guidant, based in Indianapolis, Indiana, estimates that nearly 750,000 people worldwide undergo a percutaneous procedure that requires a balloon angioplasty catheter.