AtriCure Announces the Release of the AtriClip FLEX

AtriCure Inc. has introduced the AtriClip 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 currently is available in the United States, Europe and other areas.

The AtriClip is used 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 left atrial appendage management (LAAM) in Afib patients, surgeons often exclude the appendage to prevent clot formation. The company has sold more than 35,000 AtriClip devices worldwide since the product’s 2010 market introduction.

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

AtriClip has a U.S. 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.

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

In early 2014, AtriCure initiated the Stroke Feasibility Study 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.

AtriCure develops atrial fibrillation (Afib) treatment. AtriCure’s Synergy Ablation System is a surgical device approved for the treatment of Persistent and Longstanding Persistent forms of Afib in patients undergoing certain open concomitant procedures. The company is based in West Chester, Ohio.