Atricure has announced the introduction of the AtriClip Flex, a new device used in left atrial appendage occlusion for stroke prevention in atrial fibrillation patients. According to a company release, the device has a more flexible aluminum shaft that allows surgeons to better manoeuvre 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 atrial fibrillation. The AtriClip Flex device is currently available in the United States, with availability in Europe and other geographies coming later this year.
“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,” says Theodore S Wright, cardiothoracic surgeon at Gill Heart Institute, University of Kentucky HealthCare, Lexington, USA, who was the first surgeon to use the AtriClip Flex device.
AtriClip has a Food and Drug Administration indication for the occlusion of the left atrial appendage under direct visualisation, in conjunction with other open cardiac surgical procedures. The Left Atrial Appendage Exclusion System portfolio includes the AtriClip Pro, AtriClip long and AtriClip standard, which have different lengths and deployment features.
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 cannot take long-term anticoagulation medications. Complete exclusion of the left atrial appendage 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.