FDA panel gives AtriCure good news on Synergy system

Ohio's AtriCure ($ATRC) got good news from an FDA expert panel yesterday on its Synergy ablation system for treating atrial fibrillation during open-heart concomitant surgical procedures. The panel voted 5-3 with one abstention to recommend approval, Bloomberg reports.

The system includes AtriCure's Isolator Synergy clamps, a radiofrequency generator and related switchbox. It is currently cleared in the U.S. for cardiac tissue ablation during concomitant open-heart surgeries.

To help convince the experts to recommend approval, AtriCure promised it would do "extensive" physician training--something that seemed to reassure the panelists. "I think that can only add to the safety issue,'' said Robert Dubbs, the consumer representative on the panel, as quoted by Bloomberg.

"We are very pleased with the panel's approval recommendation and we look forward to working interactively with the FDA to facilitate an AF approval for our Synergy Ablation System. An AF label will result in a comprehensive surgeon training program, which we believe will optimize patient care and improve outcomes for patients with AF undergoing open-heart surgery," said David Drachman, AtriCure president and CEO, in a statement.

The vote came ahead of a meeting on Medtronic's ($MDT) percutaneous catheter system to treat persistent atrial fibrillation. The company faced some tough questions, as FDA staffers expressed concern about the safety of the device in materials posted ahead of the meeting.

The panel ended up voting 8-2 that the risks of the device outweigh its benefits. The members also voted 10-0 that the device is effective; however, they deemed it to be unsafe by a 9-1 margin. 

Despite the vote, there shouldn't be "a material impact on Medtronic," according to a note from Deutsche Bank's Kristen Stewart, as quoted by Bloomberg.

- check out AtriCure's release
- read the Bloomberg story
- get more from Bloomberg on Medtronic