AtriCure Inc.’s (NSDQ:ATRC) Synergy cardiac ablation system will undergo FDA panel review in late October as the watchdog agency considers the company’s premarket approval application.
Cardiac ablation uses either heat or cold to create precise scar tissue in the heart to correct arrhythmias, or heart rhythm problems.
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AtriCure’s Synergy system is scheduled for review with the FDA’s Circulatory System Devices Panel on October 26 for treatment of atrial fibrillation during open-heart surgery.
The company has put a lot of stock into novel approaches to treating AF, 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.
"It’s a huge opportunity for the company, one of their biggest opportunities to create value," said Matt Dolan, a senior research analyst with Roth Capital Partners, in June.
AF is also a fairly big problem and thus a large and potentially lucrative market. The American Heart Association estimates that about 2.2 million Americans suffer from the disorder (AtriCure puts the worldwide number at 5.5 million). The AHA estimates that between 3 percent and 5 percent of people older than 65 suffer from AF and about 15 percent of strokes occur in people with AF.
AtriCure is also expecting U.S. regulatory clearance for its new cryoICE BOX cryoablation system, which launched in Europe earlier this year, by the end of next quarter.