An FDA advisory panel is slated to review next month the Sentinel embolic protection device made by Claret Medical, following the company’s bid for de novo clearance last fall.

The federal watchdog’s Circulatory System Devices Panel scheduled a hearing for Feb. 23 to review the clearance bid for Sentinel, which is designed to use a pair of temporary arterial filters during transcatheter aortic valve replacement to trap blood clots before they get to the brain.

Data from a pivotal trial in high-risk patients, released in November 2016, failed to meet the primary efficacy endpoint,  although Sentinel met the primary safety endpoint. The 360-patient study had a primary efficacy endpoint of reduction in median new lesion volume in protected territories, assessed by MRI at 2 to 7 days, and a primary safety endpoint of major adverse cardiac and cerebrovascular events at 30 days.

Patients were randomized 1:1:1 to either treatment using Sentinel during TAVR and 2 imaging cohorts for TAVR with or without the Sentinel device. The rate of MACCE was 7.3% in both arms that used the Claret Medical device and 9.9% in the control arm, for no statistically significant difference. The rate of all strokes at 30 days was likewise not significantly different at 5.6% in the device arms and 9.1 in the control group. The median total new lesion volume in protected territories was 102.8mm³ for the Sential cohorts, compared with 178.0mm³ for the just-TAVR group.

Important confounders included transcatheter valve type and baseline MRI lesion volume (a marker for baseline cerebral disease burden). After adjusting for these factors, embolic protection resulted in reduction of new lesion volume on MRI, but there was no significant improvement in neurocognitive function associated with embolic protection.

Santa Rosa, Calif.-based Claret filed for FDA clearance in September 2016 for Sentinel, which won CE Mark approval in the European Union in 2013.