The AtriCure has obtained the US Food and Drug Administration (FDA) clearance to commence three-year Ablate post approval study (PAS), designed for the surgical correction of atrial fibrillation.
The 350 patient study is designed to provide additional evidence on the safety, efficacy and long-term durability of the Maze IV concomitant treatment for AF using the company’s Synergy ablation system.
The study is a follow-up to the company’s 14 December 2011 FDA approval of the ablation system, designed to treat chronic forms of AF known clinically as ‘non-paroxysmal AF’.
The initial FDA approval study demonstrated that 84% patients are free from AF at six months following Maze IV treatment and 75% of patients are free of AF at a mean follow-up of 22 months when assessed by 48-hour Holter monitors.
Northwestern university feinberg school of medicine Bluhm Cardiovascular Institute director and PAS Executive Committee chair Patrick McCarthy said the Ablate post approval study will provide the evidence to validate the treatment of the underserved patients with intractable forms of AF.
"This trial represents the most comprehensive experience for any treatment option for atrial fibrillation, and we’re looking forward to this significant study designed to treat patients with this life-threatening condition," McCarthy added.
AtriCure founder Michael Hooven said the trial data suggests that currently only 3 in 10 cardiac surgery patients with an AF diagnosis receive an AF procedure and only 1 in 10 receive a complete Maze IV procedure.
"We expect the PAS study will provide additional compelling evidence of the benefits of the AtriCure Maze IV procedure and be a catalyst for making it the standard of care," Hooven added.