Circulatory System Panel
This article was originally published in The Gray Sheet
Executive Summary
Cardiac Pathways' premarket approval application for the Chilli cooled ablation system will be reviewed by the advisory panel on July 21 in Gaithersburg, Maryland. The catheter radiofrequency ablation system is designed to treat patients with ventricular tachycardia and is undergoing expedited review ("The Gray Sheet" April 6, In Brief). The potential patient population targeted for treatment with the device is the estimated 160,000 of 400,000 Americans per year who suffer VT or are at risk for the disease. On July 22, the panel will provide FDA with input on clinical trial design for cardiac ablation devices for treatment of atrial fibrillation and atrial flutter. For more information contact FDA's advisory committee information line at 800/741-8138 and use code 12625...