CARLSBAD, Calif., May 13, 2022 (GLOBE NEWSWIRE) — Acutus Medical (AFIB), an arrhythmia management company focused on improving how cardiac arrhythmias are diagnosed and treated, today announced the successful patient enrollment in the company’s AcQForce™ Flutter program Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at 21 sites worldwide.
The AcQForce Flutter trial was designed to assess the safety and efficacy of the AcQBlate FORCE catheter and sensing ablation system in the treatment of typical right atrial flutter. Right atrial flutter occurs when rapidly transmitted electrical signals cause the muscles in the upper chamber of the heart (atria) to contract rapidly, resulting in a rapid heartbeat and may include symptoms such as chest pain, shortness of breath, dizziness and fainting.1. A rapid and sustained heartbeat can also put pressure on the heart and slow the movement of blood through the atria, increasing the risk of stroke, among other comorbidities.2.
Catheter ablation procedures to treat right atrial flutter account for approximately 30% of ablations in the United States and are expected to reach 200,000 by 20252. The complete AcQBlate FORCE catheter and sensing ablation system, which received full CE marking in late 2020, is commercially available in Europe. The company anticipates final patient follow-up in June 2022 with the submission of pre-market approval (PMA) of the AcQBlate FORCE catheter and sensing ablation system in the third quarter of this year.
Designed specifically to provide consistent and effective therapy solutions during cardiac ablation procedures, the AcQBlate FORCE system provides physicians with real-time contact force applied to the heart during ablations. Studies have shown the value of real-time contact force information in helping physicians guide safe and effective treatment, which can improve patient outcomes.3.
Dr. Vijay Swarup, MD, FHRS, Director of Cardiac Electrophysiology at the Arizona Heart Rhythm Center, and one of the trial’s principal recruiters, said, “I am pleased with the performance of the AcQBlate FORCE Sensing Ablation System. Ablation in the AcQForce Flutter assay. The integration of the ablation system into the AcQMap 3D mapping system makes it easy to incorporate this new force sensing technology into my workflow. I’m particularly impressed with the system’s flexibility to operate both on its own and when integrated with Acutus mapping technology.
“Completing enrollment in the AcQForce Flutter trial represents a significant step forward in our journey to enter the United States with therapeutic technology for the treatment of atrial flutter,” said David Roman, Interim Chief Executive Officer and Director financial institution of Acutus Medical. “Acutus has a long history of partnering with physicians to bring innovative technology to market to treat atrial arrhythmias, and we are grateful to our clinical trial sites, especially the dedication and commitment of researchers and their staff, and to our clinical team for their collaboration in achieving this milestone.
For more information on this trial, please see NCT04658940 at https://www.clinicaltrials.gov. The AcQBlate Force Sensing Catheter is limited by US federal law to investigational use.
- American Heart Association
- Boyer M and Kaplan B, Atrial Flutter, Circulation (2015); 112:e334-e336
- Electrophysiology Mapping and Ablation Devices, Market Insights, USA. Decision Resources Group M360EP0062, June 2020
- Ariyarathna N. et al., Role of contact force sensing in catheter ablation of cardiac arrhythmias: evolution or repeating history? 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 line of products and technologies that will enable more physicians to treat more patients more effectively and efficiently. Through internal product development, acquisitions and global partnerships, Acutus has established a global commercial presence offering a broad portfolio of highly differentiated electrophysiology products that provide 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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