AtriCure has announced FDA approval of the ABLATE Post Approval Study (PAS). This three-year, 350-patient study is a follow-up to the company’s 14 December 2011 FDA approval of the AtriCure Synergy Ablation System for the surgical treatment of atrial fibrillation (AF). AtriCure is the first and only surgical company with a specific, on label indication for AF.
The PAS study is intended to build additional evidence on the safety, efficacy and long-term durability of the Maze IV concomitant treatment for AF using AtriCure’s proprietary surgical devices.
The initial FDA approval study, ABLATE, reported 84% of patients free from AF at six months following Maze IV treatment and 75% of patients free of AF at a mean follow-up of 22 months when assessed by 48-hour Holter monitors. The Maze IV procedure is normally performed at the time of a primary open heart procedure where access to the heart is routinely established.
The ABLATE and PAS studies focus on the most difficult to treat, chronic forms of AF known clinically as non-paroxysmal AF. The chronic AF patient group represents roughly half of the diagnosed patient population and has been extremely challenging to manage with conventional medical therapy or catheter ablation.
According to Patrick McCarthy, director of the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine and Chair of the PAS Executive Committee, “The ABLATE Post Approval Study represents an important study which will provide the evidence to validate the treatment of these underserved patients with intractable forms of AF,” he said. “This trial represents the most comprehensive experience for any treatment option for atrial fibrillation, and we are looking forward to this significant study designed to treat patients with this life-threatening condition.”
The company’s founder, Michael Hooven, is optimistic about the FDA approval and the PAS. “Receiving the first and only FDA approval for the surgical treatment of atrial fibrillation was a major milestone for AtriCure. We are now able to fulfill our mission of improving patient outcomes by offering a standardised surgeon training programme focused on the Maze IV procedure. Our data suggest that currently only three in 10 cardiac surgery patients with an AF diagnosis receive an AF procedure and only one 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.”
Concurrently with the post-approval study, AtriCure is sponsoring an extensive Maze IV training programme for cardiovascular surgeons. This course was developed by recognised leaders in the field of surgical ablation and is recognised by the Society of Thoracic Surgeons as an Endorsed Industry Education Program. For more information about this course, visit targetaf.com.