Acutus Medical completes enrollment in IDE trial with its AcQBlate FORCE Sensing Ablation System
Carlsbad, Calif. -- Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today 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.”
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
About Acutus Medical
Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.
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