LAGUNA HILLS, CA., July 28, 2022 /PRNewswire/ — Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the publication of results from its ultra -low temperature Cryocure-2 (ULTC) study in patients with AF in the Journal of American College of Cardiology (JACC), Clinical Electrophysiology.1 The study prospectively recruited 79 patients at OLV Hospital in Aalst, BelgiumSt. Antonius Hospital in Nieuwegein, Netherlands and University of Bordeaux, Bordeaux, France, of which 45 patients had persistent AF (PsAF). Freedom from AF over one year after a single procedure was 82%, with a procedural complication rate of 1.5% when using ULTC technology. In patients with PsAF, freedom from AF was 85%.
“We presented preliminary results from Cryocure-2 at the 2021 Heart Rhythm Society meeting in Boston“, said Dr. Tom De Potter, MD, Associate Director, Department of Cardiology, Cardiovascular Center, Section of Electrophysiology, OLV Hospital, and first author of the manuscript. “Today’s publication reaffirms the interest from the EP community for ULTC technology for the treatment of AF and other cardiac arrhythmias. The 85% absence of AF in patients with PsAF after a single percutaneous procedure is by far the best outcome reported in these patients and warrants conformation in the larger study, which is currently underway. »
“Almost all patients with persistent AF in the Cryocure-2 study underwent ablations that combined pulmonary vein isolation with additional lesions, primarily on the posterior wall of the left atrium,” added Lucas BoersmaMD, PhD at St. Antonius Nieuwegein Hospital, Netherlands and professor at the UMC in Amsterdam. “There is a preponderance of clinical evidence indicating that additional lesions improve ablation efficacy in patients with persistent AF, however, the creation of such lesions using traditional RF and CT ablation procedures cryoballoon therapy is often too cumbersome as a first-line treatment.The unique feature of the Adagio catheter design is the little extra work these lesions require, adding only 7 minutes to procedure time at experienced Cryocure-2 sites. We are now integrating this approach into routine clinical practice.
The Adagio Medical iCLAS™ cryoablation system has received CE marking and is marketed in Europe. The Cryocure-PMCF open-label post-marketing clinical follow-up evaluation (NCT # 05416086) of the iCLAS System is recruiting patients with paroxysmal and persistent AF from multiple European centers. The safety and effectiveness of the iCLAS System for the treatment of persistent AF is under investigation by the FDA in the United States (NCT # 04061603).
“The release of Cryocure-2 data is considered a significant step in the validation of Adagio’s ULTC technology,” said Olav Bergheim, Chairman and CEO of Adagio Medical. “As additional data on ULTC results becomes available,2 we have high expectations for the results of our ongoing FDA IDE trial. We also believe that iCLAS results data will promote recognition of Adagio technology in both Europe and in the United States and will contribute to increased penetration of catheter ablation in the large and growing AF patient population, which is an underserved market today. »
About Adagio Medical
Adagio Medical, Inc. (www.adagiomedical.com) is a private company located in Laguna Hills, California, which develops innovative cryoablation technologies that create contiguous and transmural lesions to treat cardiac arrhythmias, including paroxysmal atrial fibrillation and persistent, atrial and ventricular flutter. tachycardia. Adagio Medical, Inc. is a portfolio company of Fjord Ventures.
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1 De Potter T, Klaver M, Babkin A, Iliodromitis K, et al. Ultra-low temperature cryoablation for atrial fibrillation: primary endpoints of efficacy and safety: the Cryocure-2 study. J Am Coll Cardiol EP 2022; available online at https://www.sciencedirect.com/science/article/pii/S2405500X22004972
2 Tohoku S, Schmidt B, Bordignon S, Chen S, et al. Initial clinical experience of pulmonary vein isolation using the ultralow temperature cryoablation catheter for patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2022;1–9.
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SOURCEAdagio Medical, Inc.