The FDA’s circulatory system devices panel has Medtronic Inc. (NYSE:MDT), AtriCure Inc. (NSDQ:ATRC) and Cook Medical in its sights for panel review next month.
Medtronic and AtriCure are both hoping to get the panel’s nod for cardiac ablation devices, and Cook is working toward clearance for its drug-eluting stent.
On October 13, the FDA’s panel will vote on Cook’s Zilver-PTX drug-eluting stent coated in paclitaxel, the same drug used in Boston Scientific Corp.’s (NYSE:BSX) Taxus DES.
The device is currently undergoing a randomized clinical trial in 55 clinics across the U.S., Japan and Germany, as well as a single-arm trial conducted at 30 sites in Europe, Canada and Korea.
The watchdog agency’s circulatory devices panel will meet again on October 26 and 27 to review cardiac ablation device made by Medtronic and by AtriCure.
Cardiac ablation uses either heat or cold to create precise scar tissue in the heart to correct arrhythmias, or heart rhythm problems.
Medtronic’s Ablation Frontiers devices, which the med-tech goliath acquired in Feb. 2009, won CE Mark approval in the European Union in 2006 and won a nod from Canadian regulators in August 2010.
The FDA will vote on the device’s catheters and ablation generator next month.
AtriCure’s Synergy device complements its rich portfolio of atrial fibrillation treatment systems, including including "hybrid" procedures using a combination of ablation from the inside and outside of the heart, which it calls DEEP (dual epicardial/endocardial procedure) AF.
AtriCure is also expecting U.S. regulatory clearance for its cryoICE BOX cryoablation system, which launched in Europe earlier this year, by the end of next quarter.
