FDA Gives Green Light on Post Approval Clinical Study of Surgical Ablation System
Published date : 24 September 2012
Article date : 24 September 2012
Massdevice reports that the FDA has given the go-ahead on AtriCure's 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. Previous Synergy studies found that 84% of patients were free from AF at 6 month following treatment, and 75% remained AF-free at 22 months.
According to the manufacturer, the device was the 1st surgical ablation system approved by the FDA for treating AF and the 1st approved for treating persistent and long-standing persistent AF. The FDA cleared the Synergy device for cardiac ablation during concomitant open-heart surgical procedures.
Source: Massdevice 17 September 2012
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