FDA Issues Alert For LAA Closure Device
The U.S. Food and Drug Administration (FDA) on July 13 issued an alert for SentreHEART’s LARIAT Suture Delivery Device, used to close the left atrial appendage (LAA) in patients with atrial fibrillation (AFib). The FDA has found 45 adverse events through June 30 of this year that occurred in patients undergoing LAA closure with this device, including death, laceration of the heart, complete LAA detachment from the heart, hypotension, hemorrhage, pericardial effusion, cardiac tamponade, and pleural effusion.
In the FDA announcement, the agency states that health care providers should “be aware that the safety and effectiveness of the LARIAT Suture Delivery Device to close the LAA and prevent stroke in patients with [AFib] has not been established.”
The FDA also notes that it will continue to monitor the issue closely.
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