CE Mark approval for AtriClip System

Oct 7 2009

AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems, today announced CE Mark approval for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System. The AtriClip System is designed to safely and effectively exclude the left atrial appendage and is being launched in Europe through a phased approach during the fourth quarter.

The system was successfully utilized this week in multiple European centers during both open-heart and minimally invasive cardiac procedures. The first cases were performed at the University of Zurich in Switzerland by Professor Volkmar Falk and Dr. Sacha Salzberg. “The AtriClip System was intuitive to use and resulted in a safe and complete exclusion of the left atrial appendage,” said Professor Falk. “This is a very promising advancement for exclusion of the left atrial appendage. We look forward to further use and evaluation of this system.”

“European approval of the AtriClip System represents a major product and clinical milestone for AtriCure,” said David J. Drachman, President and Chief Executive Officer. “We believe that the AtriClip System provides a safe, efficient and clinically superior method to exclude the left atrial appendage. This key innovation represents a large and exciting new growth platform and we look forward to full commercial release in Europe and the United States during 2010.”

EACTS Satellite Symposium

On October 19, 2009, the AtriClip System will be highlighted during a symposium at the EACTS annual meeting in Vienna, Austria, a meeting for cardio-thoracic surgeons that has over 3,000 physician attendees. The symposium, entitled “The Left Atrial Appendage: Rewards and Challenges,” will be lead by Dr. Michael J. Mack, Medical Director of Cardiovascular Surgery, Baylor Healthcare System and Chairman of the Heart Hospital – Baylor Plano Research Center. Dr. Mack, the principal investigator of the FDA multi-center trial for the AtriClip System, EXCLUDE, will be joined by Dr. Salzberg, the principal investigator of the European trial for the AtriClip System, to discuss their respective clinical trial results using this novel system.

http://www.atricure.com/