Acutus Medical has announced initial US enrolment in the company’s AcQForce Flutter Investigational Device Exemption (IDE) clinical trial. The trial is expected to enrol up to 150 subjects in centres globally and will evaluate the safety and efficacy of the AcQBlate FORCE sensing ablation catheter and system in the treatment of right atrial typical flutter
AcQBlate FORCE can operate both in a standalone manner or in conjunction with a compatible 3D mapping system, Acutus said in a press release. The system is comprised of Acutus’ AcQBlate FORCE catheter and Qubic Force module, integrating an RF generator and irrigation pump. The AcQBlate FORCE sensing ablation catheter and system, which received full CE mark in late 2020, is now commercially available in Europe.
“The AcQBlate FORCE sensing ablation catheter provides stable contact force readings with low fluid irrigation requirements. It displayed both easy manoeuvrability and excellent stability during atrial ablation. I look forward to further evaluating this system and believe this technology has the potential to improve patient outcomes,” said Gery Tomassoni of Baptist Health Medical Group in Lexington, USA, who performed the first case in the trial.
Sean Beinart of Adventist Healthcare White Oak Medical Center in Silver Springs, USA, further commented: “The system was very easy for our lab staff to set up, and we were able to complete the case without changing our existing workflow. As the incidence of atrial arrhythmias increases, we continue to look for safe, effective and efficient treatment options for patients. The AcQBlate FORCE sensing ablation catheter incorporates a gold-tipped electrode that is designed for efficient energy delivery and effective lesion creation in less time.”
“This trial represents our initial entry into the USA with a therapeutic technology for the treatment of atrial arrhythmias,” said Vince Burgess, CEO of Acutus Medical. “The gold-tipped AcQBlate FORCE catheter is a state-of-the-art ablation device that is paired with our laser-based contact force console and further integrated with the smallest and most modern RF generator and pump available. As we have experienced in our European centres during our initial market release, when used in concert with our novel AcQMap 3D mapping system we are seeing highly efficient workflow and operational efficiency. We look forward to offering the benefits of a comprehensive, force sensing ablation system to electrophysiologists and patients in the USA once we complete clinical trials and gain regulatory approval.”