Acutus Medical Receives Green Signal From FDA To Start AcQBlate Atrial Fibrillation Trial

The FDA has signed off Investigational Device Exemption (IDE) AcQBlate AF trial for Acutus Medical Inc's AFIB AcQBlate Force Sensing Ablation Catheter and System.
The trial is expected to enroll 350 subjects and evaluate the system's safety and efficacy in the treatment of both paroxysmal and persistent atrial fibrillation.
The system is designed to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate Force gold-tipped catheter, and the system shows physicians, in real-time, how much contact force is being applied to the heart during ablations.
Enrollment for the AcQBlate Force AF trial is expected to begin in the second half of 2021, once participating sites gain necessary institutional review board (IRB) approvals.
Price Action: AFIB shares are up 7.9% at $15.43 during the premarket session on the last check Thursday.