FDA OKs AtriCure's AF ablation post-approval study | Regulatory Roundup
The FDA approves AtriCure's post-approval clinical study of its Synergy surgical ablation system in treatment of chronic atrial fibrillation.
AtriCure wins FDA OK to launch post-approval clinical study of AF ablation
AtriCure (NSDQ:ATRC) won FDA approval to launch a post-approval clinical study of its Synergy radiofrequency ablation system in treatment of non-paroxysmal atrial fibrillation, a chronic and hard-to-treat heart disease.
The new 3-year, 350-patient ABLATE study follows the West Chester, Ohio-based device maker's December 2011 FDA win for the Synergy ablation system, indicated for treatment of AF during open-heart surgery.