Adagio Medical has announced the publication of the results of its Cryocure-2 ultra-low temperature cryoablation (ULTC) study in patients with atrial fibrillation (AF) in the Journal of American College of Cardiology (JACC), Clinical Electrophysiology.
The study prospectively enrolled 79 patients at OLV Hospital (Aalst, Belgium), St Antonius Hospital (Nieuwegein, The Netherlands) and University of Bordeaux (Bordeaux, France) of which 45 patients had persistent AF (PsAF). The one-year freedom from AF after a single procedure was 82%, with 1.5% procedural complications rate when using ULTC technology. In PsAF patients, freedom from AF was 85%, Adagio Medical reports in a press release.
“We reported preliminary results of Cryocure-2 at the 2021 Heart Rhythm Society meeting in Boston,” said Tom De Potter (OLV Hospital, Aalst, Belgium) and the first author of the manuscript. “Today’s publication reaffirms the interest of the EP community in ULTC technology for the treatment of AF and other cardiac arrhythmias. The 85% freedom from AF in PsAF patients after a single percutaneous procedure is by far the best result reported in such patients, and needs conformation in the larger study, which is currently ongoing.”
“Almost all patients with persistent AF in the Cryocure-2 study underwent ablations which combined pulmonary vein isolation with additional lesions, mostly on the posterior wall of the left atrium,” added Lucas Boersma (St. Antonius Hospital Nieuwegein, The Netherlands and Amsterdam UMC, Amsterdam, The Netherlands). “There is a preponderance of clinical evidence that additional lesions improve effectiveness of the ablation in persistent AF patients, however, creating such lesions using traditional radiofrequency and cryoballoon ablation procedures is often too burdensome as a first-line treatment. The unique feature of Adagio’s catheter design is how little incremental work those lesions require, adding only seven minutes to the procedure time at the experienced Cryocure-2 sites. We are now incorporating this approach into routine clinical practice.”
Adagio Medical iCLAS cryoablation system received CE mark and is commercial in Europe. The Cryocure-PMCF open-label post-market clinical follow-up evaluation of the iCLAS system is enrolling both paroxysmal and persistent AF patients at several European centres. The safety and effectiveness of the iCLAS system for the treatment of persistent AF is a subject of a US Food and Drug Administration (FDA) investigational device exemption (IDE) trial in the USA.