Acutus Medical Completes Enrollment in IDE Trial with its AcQBlate FORCE Sensing Ablation System

Acutus Medical, an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, announced successful completion of patient enrollment in the company’s AcQForce Flutter Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at 21 sites globally

May 13, 2022 — Acutus Medical, an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, announced successful completion of patient enrollment in the company’s AcQForce Flutter Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at 21 sites globally.

The AcQForce Flutter trial 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. Right atrial flutter occurs when rapidly firing electrical signals cause the muscles in the heart’s upper chamber (atria) to contract quickly, leading to a rapid heartbeat and can include symptoms such as chest pain, shortness of breath, dizziness, and fainting¹. A sustained rapid heartbeat can also put stress on the heart and slow the movement of blood through the atria, increasing the risk of stroke, among other comorbidities².

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 2025². The complete AcQBlate FORCE sensing ablation catheter and system, which received full CE Mark in late 2020, is commercially available in Europe. The company anticipates final patient follow-up in June 2022 with Pre-Market Approval (PMA) submission of the AcQBlate FORCE sensing ablation catheter and system in the third quarter of this year.

Designed specifically to provide consistent, effective therapeutic solutions during cardiac ablation procedures, the AcQBlate FORCE system shows physicians, in real-time, how much contact force is being applied to the heart 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 outcomes³.

Dr. Vijay Swarup, MD, FHRS, Director of Cardiac Electrophysiology at the Arizona Heart Rhythm Center, and one of the leading enrollers in the trial, said, “I am pleased with the performance of the AcQBlate FORCE Sensing Ablation System in the AcQForce Flutter trial. The integration of the ablation system into the AcQMap 3D Mapping System helps the incorporation of this new force sensing technology into my workflow. I am particularly impressed by the flexibility of the system to operate both in a standalone manner and when integrated into the Acutus mapping technology.”

“Completing enrollment in the AcQForce Flutter trial represents a significant advancement in our journey to enter the United States with a therapeutic technology for the treatment of atrial flutter,” said David Roman, interim Chief Executive Officer and Chief Financial Officer of Acutus Medical. “Acutus has a strong history of partnering with physicians to bring innovative technology to the market to treat atrial arrhythmias, and we are thankful to our clinical trial sites, specifically the dedication and commitment of investigators and their staff, and to our clinical team for their collaboration in reaching this milestone.”

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.

For more information: https://www.acutusmedical.com/us/

References

American Heart Association
Boyer M and Kaplan B, Atrial Flutter, Circulation (2015); 112:e334-e336
Electrophysiology Mapping and Ablation Devices, Market Insights, US. Decision Resources Group M360EP0062, June 2020
Ariyarathna N. et al., Role of Contact Force Sensing in Catheter Ablation of Cardiac Arrhythmias: Evolution or History Repeating Itself? JACC: Clinical Electrophysiology (2018); 707-723