Adagio Medical has announced first-in-human cases of pulsed field cryoablation (PFCA) for the treatment of atrial fibrillation (AF).
The cases were performed at Medicover Hospital, Warsaw, Poland by Pawel Derejko, head of the Department of Cardiology at Medicover and Atul Verma, director of Arrhythmia Services at Southlake Regional Medical Centre, Newmarket, Ontario, Canada, and an associate professor at the University of Toronto.
The patients, a 32-year-old man with paroxysmal AF and a 60-year-old man with persistent AF underwent successful pulmonary vein and posterior wall isolation using a dedicated PFCA catheter powered by the proprietary Adagio iCLAS cryoablation and pulsed field ablation (PFA) consoles.
“PFCA is a unique combination of Adagio’s ultra-low temperature cryoablation (ULTC) followed immediately by PFA, using the same catheter,” said Verma. “Physiologically, the short-duration ULTC coats the catheter with ice and pre-freezes targeted myocardial tissue, focusing pulsed electric field to the frozen areas, and reducing aberrant electric currents elsewhere. Clinically, this translates into the prevention of skeletal muscle contraction, phrenic nerve capture, and microbubbles which can be associated with traditional PFA, all while providing effective acute isolation. The ice-coated catheter allows us to deliver higher voltage pulses without those unwanted effects. Furthermore, ULTC promotes stable tissue contact and lesion contiguity without the need for catheter repositioning. These benefits were first observed in the pre-clinical work reported earlier this year, and now have been confirmed in the first-in-human cases. We are looking forward to advancing this technology into larger studies and establishing chronic durability of the PFCA approach.”
“Ultra-low temperature cryoablation was founded on the premise that durability, contiguity and transmurality of myocardial lesions result in better long-term outcomes of cardiac arrhythmia ablations,” said Olav Bergheim, president and CEO of Adagio Medical. “The combination of ULTC and PFA into PFCA takes advantage of the benefits and overcomes the limitations of both technologies. Our immediate plans are to initiate a prospective, multicentre study to support future CE-mark approval and early feasibility study in the USA.”