MEDTRONIC INITIATES TRIAL OF CARDIOBLATE SURGICAL ABLATION SYSTEM

Medtronic announced it is beginning a U.S. trial of the Cardioblate surgical ablation system for treatment of permanent atrial fibrillation (AF).

The CURE-AF trial will evaluate the system's safety and effectiveness in reestablishing normal heart rhythms in patients with permanent AF requiring concomitant open-heart surgery using the modified Cox Maze III procedure.

The prospective, non-randomized trial will enroll patients at 10 sites. The primary endpoint is the freedom from permanent AF in patients not taking antiarrhythmic drugs at six months.

The system is an irrigated radio-frequency surgical ablation system used to create lesions on the heart muscle to block irregular signals of the heart, with the goal of reestablishing normal heart rhythm.