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AtriCure Announces the Release of the AtriClip(R) FLEX

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AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments for atrial fibrillation (Afib) and Left Atrial Appendage Management (LAAM), today announced the introduction of the AtriClip(R) FLEX, a new device with a more flexible aluminum shaft that allows surgeons to better maneuver within a patient’s particular anatomy.

The device is one of four products within the AtriClip Left Atrial Appendage Exclusion System portfolio used in patients who suffer with Afib. The AtriClip FLEX device is currently available in the United States, with availability in Europe and other geographies coming later this year.

The AtriClip is utilized by cardiac surgeons to occlude the left atrial appendage, a small muscular pouch attached to the left atrium of the heart. Since research indicates more than 90 percent of blood clots develop in the LAAM in Afib patients1, surgeons often exclude the appendage to prevent clot formation. AtriClip is the most widely used LAAM occlusion device with more than 35,000 sold worldwide since its introduction to the market in 2010.

The introduction of the new AtriClip FLEX with the malleable deployment tool shows AtriCure’s commitment to constant improvement, to patients, and to the physicians who treat them on a daily basis,” said Dr. Theodore S. Wright, cardiothoracic surgeon at Gill Heart Institute, University of Kentucky HealthCare who was the first surgeon to use the AtriClip FLEX device.

AtriClip has a Food and Drug Administration indication for the occlusion of the LAAM under direct visualization, in conjunction with other open cardiac surgical procedures. The LAAM Exclusion System portfolio includes the AtriClip PRO, AtriClip long and AtriClip standard, which have different lengths and deployment features.

“AtriCure is dedicated to developing medical devices that solve complex problems and improve the lives of patients,” said Mike Carrel, chief executive officer of AtriCure. “AtriClip FLEX is a good example of how we listen and respond to the unique needs of surgeons.”

Patients who suffer from Afib have a 500 percent greater risk of stroke, compared with the general population.2 Afib-related strokes are associated with higher morbidity and mortality than non-Afib related strokes.3 More than 5.2 million people in the United States4, and more than 33 million people worldwide5, suffer with atrial fibrillation.

In early 2014, AtriCure initiated the Stroke Feasibility Study (NCT01997905) using the AtriClip System in a minimally invasive procedure on a beating heart. This study will evaluate the safety of the AtriClip System when used for stroke prevention in patients with non-valvular atrial fibrillation who can’t take long-term anticoagulation medications. Complete exclusion of the LAAM will be confirmed during the procedure using echo graphic imaging. The study will be conducted at seven hospitals in the United States, enrolling up to 30 patients.

About AtriCure

AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation. AtriCure’s SynergyTM Ablation System is the first and only surgical device approved for the treatment of Persistent and Longstanding Persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip Left Atrial Appendage Management (LAAM) exclusion device is the most widely sold device worldwide that’s indicated for the occlusion of the LAAM. The company believes cardiothoracic surgeons are adopting its ablation and LAAM devices for the treatment of Afib and reduction of Afib related complications such as stroke. Afib affects more than 33.5 million people worldwide. 5

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1. Jeff S. Healey, MD, Eugene Crystal, MD, Andrew Lamy, et al. “Left Atrial Appendage Occlusion Study (LAAOS): Results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in patients at risk for stroke.” American Heart Journal. 2005 Aug; 150:288-93.

2. Benjamin EJ, Chen PS, Bild DE, et al. “Prevention of atrial fibrillation: report from a national heart, lung, and blood institute workshop.” Circulation. 2009 Feb 3; 119(4):606-18.

3. Marini C, De Santis F, Sacco S, et al. “Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study.” Stroke. 2005 Jun; 36 (6):1115-9.

4. Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X, et al.Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population.” American Journal of Cardiology. 2013 Oct. 15; 112 (8):1142-7.

5. Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, et al. “Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study.” Circulation. 2014 Feb 25; 129 (8):837-47.

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