Healthcare Industry News:  AtriCure 

Devices Cardiology Regulatory

 News Release - October 6, 2009

AtriCure Announces European Approval for its AtriClip System

WEST CHESTER, Ohio, Oct., 6--(HSMN NewsFeed)--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.

About the Left Atrial Appendage and the AtriClip System

The AtriClip System includes a clip device that is designed to exclude the left atrial appendage, a hollow sac-like structure attached to the heart’s left atrium. The left atrial appendage has internal peaks and valleys, or trabeculations. During AF, stagnant blood pools in the trabeculations of the left atrial appendage and is known to form clots that can migrate to other parts of the body. The AtriClip is designed to be implanted from the outside of the heart, avoiding contact with circulating blood and eliminating blood flow between the left atrial appendage and the atria.

About AtriCure, Inc.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator® bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator system as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. The FDA has cleared the AtriCure Isolator system and AtriCure’s multifunctional pen and CoolrailTM linear ablation device, for the ablation, or destruction, of cardiac tissue during surgical procedures. Additionally, the FDA has cleared AtriCure’s multifunctional pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias and AtriCure’s Cryo1 system for the cryosurgical treatment of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF.


Source: AtriCure

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