The watchdog agency granted an investigational device exemption for the trial of the AtriClip device, which is designed to exclude the left atrial appendage, in patients "at significant risk of stroke as well as substantial bleeding risks that contraindicate them for anticoagulation therapy," according to a press release.
Although the device is already approved for LAA exclusion in open heart surgeries, the new study is slated to see patients implanted with the device via a minimally invasive procedure involving a small incision in the chest wall, according to the release.
"The Stroke Feasibility IDE study is significant because it is the 1st of its kind to focus entirely on a group of untreated and under-treated afib patients that may benefit the most from total and permanent exclusion of their left atrial appendage," AtriCure president & CEO Michael Carrel said in prepared remarks. "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."
"Managing high-risk afib patients requires balancing the risk of stroke against the risk of major bleeding," added principal investigator Dr. Basel Ramlawi of the Houston Methodist DeBakey Heart Center. "This study is a major step toward developing the clinical evidence necessary to establish a viable, safe and attractive alternative to life-long anticoagulation in afib patients that currently have very limited options. This will have a favorable impact on patients and the healthcare system overall."