Medtronic next-gen Cardioblate BP cleared by FDA
This article was originally published in The Gray Sheet
Executive Summary
Firm plans to commence a clinical trial to examine device effectiveness in treating chronic atrial fibrillation this autumn, Medtronic states Aug. 6, following July clearance of the bipolar radiofrequency ablation system for surgical procedures. The more specific indication, for which the firm plans to seek agency go-ahead, following trial completion in 2004, would allow Medtronic to market the device specifically for AF. The single-electrode, first-generation device was first cleared in February 2002 (1'The Gray Sheet" Feb. 4, 2002, In Brief)...