Adagio Medical, developer of the intelligent Continuous Lesion Ablation System (iCLAS), has announced successful pre-clinical results demonstrating its existing cryoablation catheter is also capable of ablating the tissue through pulsed field ablation (PFA) delivered via the existing array of electrodes.
“Our goal is to lead the innovation and development of true continuous, transmural lesions anywhere in the heart. Our primary technologies under development have been ultra-low temperature cryo (ULTC) and electroporation (PFA),” said Olav Bergheim, president and CEO of Adagio Medical. He further says, “Therefore, our CE-marked catheter and the catheter undergoing US IDE trials were designed to incorporate both technologies. The electrodes and the wiring in the catheters are currently activated for navigation and diagnostic purposes only. Software and hardware updates will be installed in the Adagio console to enable the PFA functionality once clinical and regulatory approvals are received.”
Alex Babkin, CTO of Adagio said: “In recent years, PFA and ULTC have become important alternatives in the field of atrial fibrillation (AF) treatment. We believe that our ULTC technology, together with PFA, creates a new treatment and delivery option, the pulsed field cryo ablation (PFCA) technology, that combines the best of both worlds.”
The company is preparing for clinical trials with the PFCA combo catheter with the goal of extending the label claim to the dual modality PFCA technology.