Medtronic expands a-fib trial outside the U.S.

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Medtronic has expanded its CURE-AF [atrial fibrillation] SM clinical program with a post-market study in Europe and Canada.

Originally only in the U.S., CURE-AF is being conducted to secure FDA approval of Cardioblate for the investigational treatment of AF. The program will now collect post-market data internationally on the efficacy of irrigated cardiac ablation with radiofrequency (RF) energy in AF patients.

The Minneapolis-based company said its CURE-AF study is investigating the treatment of AF during an open-heart operation, such as valve repair or CABG. During the procedure, a surgeon uses Medtronic’s Cardioblate system to create a pattern of transmural lesions; and the lesion pattern is modeled after the Cox Maze procedure.