Acutus Submits Premarket Approval Application for AcQBlate Force
Acutus Medical has submitted a Premarket Approval application (PMA) to the FDA for its AcQBlate Force sensing ablation catheter and system.
The catheter includes a gold tip electrode that delivers radiofrequency energy to the tissue for ablation procedures. The system also includes an irrigation pump.
The PMA is supported by positive results from an ongoing clinical trial that is evaluating the catheter and system in patients with right atrial typical flutter.
The company said it will release the full study data at the Atrial Fibrillation Symposium in Boston, Mass., Feb. 2-4, 2023.