Adagio Medical Announces Completion of Enrollment in Cryocure-VT Trial and Paves Path to CE Mark for vCLAS™ VT Ablation Catheter
LAGUNA HILLS, Calif., May 3, 2023/PRNewswire/ -- Adagio Medical, Inc., a leading innovator of catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the completion of enrollment in their Cryocure-VT trial (NCT
"For years, with much of the energy in interventional electrophysiology directed at a larger market for atrial fibrillation treatments, the field of VT ablations, and in particular new catheter technologies, has suffered from underinvestment," noted Petr Neuzil, MD, PhD, the Chief of Cardiology at Na Homolce Hospital in Prague, Czech Republic, and the highest European recruiter on the trial. "To this day, we are forced to use the RF catheters originally developed and labeled for atrial arrhythmia ablation in the much more stringent environment of a human ventricle and in a much sicker patient population. The innovative vCLAS catheter is an extension of the Adagio ULTC platform, which has been shown to be highly effective in the treatment of AF, but has been specifically designed for the treatment of ventricular tachycardias, with a bidirectionally deflectable shaft and a 15mm long ablation element capable of of creating large transmural lesions, allowing termination of arrhythmias deep in the myocardium."
"Initial data from the Cryocure-VT trial recently published in the Journal of the American College of Cardiology EP1 demonstrated the successful and efficient use of ULTC across the full range of established ablation strategies in conjunction with multiple commercially available electroanatomical mapping systems, thereby which makes it an easy-to-place technology for any TV ablation program," added Dr. Tom De Potter, associate director of the Department of Cardiology, OLV Hospital Cardiovascular Center in Aalst, Belgium, and lead author of the manuscript. "While long-term results are still being analysed, acute purely endocardial ultralow-temperature cryoablation appears to be quite effective in both ischemic and non-ischemic patients, the latter being a challenge for current RF catheters due to the medial myocardial nature. of their scars. Adagio's ULTC technology in routine clinical practice will accelerate the growth of ablation volumes for VT, initially for patients with structural heart disease and ultimately in patients with idiopathic ventricular arrhythmias."
"We thank all the Cryocure-VT investigators for their commitment to the trial, including Drs. Verma and Essebag from McGill University, Dr. Dyrda from the Montreal Heart Institute, Dr. Balt and Professor Boersma from St. Antonius Hospital in Nieuwegein. .Darma and Dinov at Leipzig Heart Centrum, Dr. Sacher at the University of Bordeaux, Dr. Arya at Halle University Hospital and Dr. Vivek Reddy at Mount Sinai Hospital in New York," said Olav Bergheim, CEO and CEO of Adagio Medical. "Based on catheter handling and good acute results, comfort with ULTC technology for VT ablations grew very quickly and towards the end we literally had to turn away enrollments. Hopefully this speaks to a broader reception once all the data is analysed, and approved by regulatory bodies, we have started our CE Mark filings and hope to put vCLAS catheters in the hands of European clinicians later this year."
1De Potter T, Balt J, Boersma L, Sacher F, et al. First-In-Human Experience with Ultra-Low Temperature Cryoablation for Monomorphic Ventricular Tachycardia. J Am Coll Cardiol EP 2023. in press.
About Adagio Medical
Adagio Medical, Inc. (www.adagiomedical.com) is a private company located in Laguna Hills, California, developing innovative cryoablation technologies that create contiguous transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, flutter atrial and ventricular tachycardia. Adagio Medical, Inc. is a portfolio company of Fjord Ventures.
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