Acutus Medical reports results from AcQForce Flutter Study

Acutus Medical announced results from the AcQForce Flutter Study "AcQForce Flutter: Force Sensing RF Ablation with Low Flow Gold Tip Catheter for Typical Flutter". Results were presented during the Late-Breaking Clinical Trials and First Report Investigations session at the AF Symposium in Boston. "We are encouraged by the positive results of the AcQForce Flutter Study and our ability to help physicians deliver more efficient ablation therapy," said David Roman, President & CEO of Acutus Medical. "The study is a critical component of our PMA submission to expand our portfolio in the United States to include a fully integrated mapping and therapy solution, and these data reinforce our conviction that AcQBlate will be an important driver of our growth plans in 2023 and over the long-term." AcQForce Flutter Study enrolled 110 patients at 21 sites globally and was designed to evaluate the safety and efficacy of the AcQBlate FORCE sensing ablation catheter and system in the treatment of right atrial typical flutter. Acute success was achieved in 94% of patients and there were no serious adverse events. Ablation time was 13.5 +/- 10.0 minutes, 33% less than comparative systems (20.0 +/- 14.0 min in BLOCK-CTI). AcQBlate required only 250.4 +/- 172.2 ml of irrigation during the procedure, significantly less than comparative systems (699 +/- 386 min in BLOCK-CTI). Overall, the study demonstrated comparable outcomes to historic controls with significantly shorter ablation time and lower fluid volumes. Acutus submitted its premarket approval application for the AcQBlate FORCE sensing ablation catheter and system on October 3, 2022 and is currently under review.