Off-Label Use of Device to Prevent Stroke in A-Fib Patients is Prevalent and Potentially Dangerous, According to Penn Medicine Study

The Lariat device, which has been cleared by the U.S. Food and Drug Administration (FDA) for soft tissue approximation (placement of a suture) during surgical procedures, is associated with a significant incidence of death and urgent cardiac surgery during its frequent off-label use to prevent stroke in patients with the irregular heartbeat known as atrial fibrillation.