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

·1 min read
  • The FDA has signed off Investigational Device Exemption (IDE) AcQBlate AF trial for Acutus Medical Inc's (NASDAQ: 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.

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