AtriCure, Inc. (NASDAQ: ATRC), the leader in surgical ablation for the
treatment of Atrial Fibrillation, has announced FDA approval of the
ABLATE Post Approval Study (PAS). This landmark three-year, 350 patient
study is a follow-up to the company's December 14, 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 percent of patients
free from AF at six months following Maze IV treatment and 75 percent 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, MD, 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 says. "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."
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 standardized surgeon training program focused on
the Maze IV procedure. Our 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."