The FDA issued a safety alert on July 13, warning of deaths and severe adverse events associated with the use of SentreHEART's Lariat suture delivery device for left atrial appendage (LAA) exclusion and preventing strokes in patients with atrial fibrillation.
As of June 30, the FDA had found 45 adverse events in patients undergoing LAA closure procedures with the device and/or associated devices, including six deaths and other serious events.
Of the 45 events, 34 required emergency heart surgery. Other events included laceration and/or perforation of the heart, complete LAA detachment from the heart, hemorrhage, hypotension, pericardial effusion, cardiac tamponade and pleural effusion.
The device is not FDA-approved for LAA closure, although the FDA said some physicians use the Lariat with other SentreHEART devices to close the LAA. In 2006, the FDA granted the Lariat 510(k) class II clearance for soft-tissue approximation.
On June 25, SentreHEART announced it had received clearance from the FDA to begin enrolling patients in the AMAZE trial, a randomized, controlled study that examines the device’s ability to close the LAA as an adjunct to ablation in patients with persistent or longstanding persistent atrial fibrillation. The company plans on enrolling up to 600 patients with atrial fibrillation who are candidates for pulmonary vein isolation catheter ablation.