AtriCure Receives FDA Go-Ahead for Investigational Study for LAA Occluder
AtriClip Left Atrial Appendage Exclusion System to be evaluated as alternative to anticoagulation therapy
November 19, 2013
November 19, 2013 — AtriCure Inc., a developer of solutions to treat atrial fibrillation, announced the U.S. Food and Drug Administration’s (FDA’s) approval to begin enrollment in a clinical study of AtriCure’s AtriClip Left Atrial Appendage Exclusion System. The study will evaluate the use of the AtriClip device to prevent stroke in patients with atrial fibrillation.
The feasibility study will enroll Atrial fibrillation patients at seven medical centers across the country. The study will focus on patients with risk factors that place them at significant risk of stroke as well as substantial bleeding risks that contraindicate them for anticoagulation therapy. Research suggests that up to 40 percent of patients are unable to take oral anticoagulants due to excessive risk of bleeding .
Patients with Atrial fibrillation have a 500 percent increased risk of stroke over the general public . Atrial fibrillation related strokes are associated with higher morbidity and mortality than non-Atrial fibrillation related strokes . Since the left atrial appendage (LAA), a muscular pouch attached to the heart, has been found to be the source of approximately 90 percent of thrombi in Atrial fibrillation patients evaluated after a confirmed stroke, this study will focus on complete and permanent mechanical closure of the LAA .
During the feasibility study, patients will undergo a minimally invasive surgical procedure. Utilizing small incisions in the chest wall surgeons will place the AtriClip device directly onto the base of the LAA while the heart is still beating. Complete exclusion of the LAA is confirmed during the procedure using echo graphic imaging. Three months following the procedure, a computed tomography (CT) scan will be performed to re-confirm complete and permanent LAA exclusion on all patients.
The AtriClip LAA Exclusion System is indicated for the occlusion of the LAA, under direct visualization, in conjunction with other open cardiac surgical procedures. AtriCure received FDA 510(k) clearance for the AtriClip device in June 2010 based upon the successful results of the EXCLUDE trial (number G080095). In this study, complete and permanent exclusion of the LAA was confirmed in 98.4 percent of patients by a three-month post procedure CT scan with zero complications or adverse events. Since launch, more than 25,000 AtriClips have been implanted worldwide.
“Managing high risk Afib (atrial fibrillation) patients requires balancing the risk of stroke against the risk of major bleeding,” said Basel Ramlawi, M.D., M.M.Sc., cardiothoracic surgeon, Houston Methodist DeBakey Heart Center and the principal investigator in the study. “This study is a major step toward developing the clinical evidence necessary to establish a viable, safe and attractive alternative to lifelong anticoagulation in Afib patients that currently have very limited options. This will have a favorable impact on patients and the healthcare system overall.”
“The Stroke Feasibility IDE (investigational device exemption) study is significant because it is the first of its kind to focus entirely on a group of untreated and undertreated Afib patients that may benefit the most from total and permanent exclusion of their left atrial appendage,” said Michael Carrel, president and CEO, AtriCure. “This study is one of three FDA trials that AtriCure is currently running as part of our strategy to be the leader in developing proven and effective solutions for the worldwide Afib epidemic.”
For more information: www.atricure.com, www.ncbi.nlm.nih.gov
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