New Products In Brief

Surgical ablation system gains PMA approval for persistent and long-standing persistent atrial fibrillation, AtriCure Inc. announces Dec. 16. Specifically, the system is approved for use during open-heart concomitant coronary artery bypass grafting and/or valve replacement or repair procedures. The approval is the first in the U.S. for a surgical AF ablation system, and for any system, catheter or surgical, for the treatment of persistent and long-standing persistent AF, according to AtriCure. “We look forward to educating physicians and patients on our surgical alternative for the treatment of AF, which we believe will raise awareness for a large number of AF patients that are currently being undertreated,” said CEO David J. Drachman. In October, FDA’s Circulatory System Devices panel endorsed the product despite concerns over safety issues and limited data. (See Also see "FDA Panel Narrowly Endorses AtriCure’s Synergy For A-Fib Ablation" - Medtech Insight, 31 October, 2011..) Current FDA-approved catheter ablation devices for AF include Johnson & Johnson/Biosense’s ThermoCool radiofrequency energy-based system and Medtronic’s Arctic Front cryo-balloon system. Both are approved for paroxysmal AF and are not used during open surgery.

Johnson & Johnson’s DePuy orthopedic division gains PMA approval for use of its AOX antioxidant polyethylene material with the firm’s Sigma rotating platform knee system and LCS Complete mobile bearing...