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.