Medtronic Inc. (NYSE:MDT) has a date with the FDA.
The Fridley, Minn.-based medical device maker is slated o go before the watchdog agency’s circulatory systems advisory panel Oct. 27 for a review of its pre-market approval application for the Ablation Frontiers cardiac ablation system.
The device, designed to treat atrial fibrillation, won a nod from Health Canada in August 2010, meaning it’s cleared for market north of the border.
Medtronic acquired one component of the system, the GENius multi-channel RF ablation generator, with its acquisitions of Carlsbad, Calif.-based Ablation Frontiers Inc. for at least $225 million in February 2009. Medtronic rolled that pickup and CryoCath Technologies Inc. of Montreal, which it bought for about $380 million in 2008, into its AF Solutions business.
CryoCath makes catheters that can deliver sub-zero temperatures to the heart to restore normal electrical signals by freezing the tissue or pathways behind the irregular quivering. In March 2010, Medtronic touted the first results from its clinical trials of CryoCath technology, claiming the therapy was far more effective at treating atrial fibrillation than drugs.