October 24, 2022 — Acutus Medical, Inc, an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated announced submission of pivotal clinical data from the AcQForce Flutter trial designed to gain marketing approval from the U.S. Food & Drug Administration (FDA) for the AcQBlate Force Sensing Ablation Catheter and System (AcQBlate FORCE). Catheter ablation procedures to treat right atrial flutter account for approximately 30% of ablations in the US and are expected to reach 200,000 by 20251.
“Submission of the AcQBlate FORCE PMA application represents a major milestone in our evolution as we expand our portfolio in the United States to include an integrated mapping and therapy system,” said David Roman, President & CEO of Acutus Medical. “The demonstrated performance of the AcQBlate FORCE in the US IDE study, along with strong commercial adoption in Europe through our direct sales force and distribution partner, Biotronik, underscores our confidence in our growth strategy for 2023 and beyond.”
The AcQForce Flutter trial was a prospective, multicenter, non-randomized study approved under an FDA Investigational Device Exemption (IDE) and conducted in Right Atrial Typical Flutter patients presenting for a de novo percutaneous cardiac ablation of the cavo-tricuspid isthmus (CTI). The trial 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 flutter2. Primary endpoints were acute procedural success defined as bidirectional CTI block, and freedom from serious adverse events seven days post procedure.
The AcQBlate Force Sensing Ablation Catheter and System includes AcQBlate FORCE – the only force-sensing ablation catheter with a gold tip electrode, Qubic RF – the smallest radio frequency (RF) ablation generator in its class, the Qiona irrigation pump, and the Qubic Force Module. In the AcQForce Flutter trial, patients undergoing treatment with the AcQBlate Force Sensing System received successful therapy with clinically meaningful results. The primary efficacy endpoint was achieved, and the study observed no serious adverse events.
The AcQForce Flutter Clinical Study Report (“CSR”) was submitted to FDA as part of the Company’s modular PMA submission strategy. The CSR provides comprehensive safety and efficacy results and a detailed analysis of the full cohort of patients in the AcQForce Flutter trial. The Company intends to present full data from the AcQForce Flutter study at the AF Symposium in February 2023.
Designed specifically to provide consistent, effective therapeutic delivery during cardiac ablation procedures, the AcQBlate FORCE system has a unique gold tip electrode, low flow irrigation, and contact force sensing capabilities. The irrigated gold tip electrode has 4x thermal conductivity compared to platinum catheters, which allows for significantly more energy delivery at a lower temperature and requires less saline flow3. Contact force show physicians, in real-time, how much force is being applied to the heart from the catheter tip during ablations. Studies have shown the utility of real-time contact force information in helping physicians guide safe and effective therapy, which may improve patient outcomes1.
- Electrophysiology Mapping and Ablation Devices, Market Insights, US. Decision Resources Group M360EP0062, June 2020
- For more information on this trial, please see NCT04658940 on https://www.clinicaltrials.gov. AcQBlate Force Sensing Catheter is limited by US Federal Law to investigational use.
- Linhart M. et al., Superiority of Gold Compared to Platinum Tip Irrigated Catheter Ablation of the Pulmonary Veins and the Cavotricuspid Isthmus: A Randomized Study Comparing Tip Temperatures and Cooling Flow Requirements. J Cardiovasc Electrophysiol. 2012 Jul; 23(7): 717–21
For more information: https://www.acutusmedical.com/us/