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Adagio Medical Receives IDE Approval from the FDA to Investigate Next-Generation vCLAS® Ventricular Ablation System
Designed to Deliver Faster, More Efficient Ablation with Improved Usability on Established, Titratable, Endocardial-Approach ULTA Platform LAGUNA HILLS,
About this update from Adagio Medical Holdings, Inc
[{"type":"text","content":"\nDesigned to Deliver Faster, More Efficient Ablation with Improved Usability on Established, Titratable, Endocardial-Approach ULTA Platform\n\n\n LAGUNA HILLS, Calif.--(BUSINESS WIRE)--\nAdagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).\n\n\n“Ventricular tachycardia remains one of the most difficult arrhythmias to treat, with current ablation approaches often limited by difficulty achieving sufficient lesion depth,” said Dr. William Stevenson, M.D., Professor of Medicine, Principal Site Investigator, Vanderbilt University Medical Center. “We have been impressed with the safety and clinical results of the initial ULTA system for treating VT in patients with ischemic and nonischemic cardiomyopathies. We are looking forward to evaluating the next generation of the system, which we anticipate will have improved catheter maneuverability and allow shorter freeze times, both factors that should reduce procedure times.”\n\n\nThe approval for IDE expansion enables Adagio to initiate a clinical sub-study designed to evaluate its next-generation vCLAS Ventricular Ablation System including the next generation vCLAS Ultra catheter, which has been built on the clinical foundation established by the Company’s all-endocardial ULTA technology. Adagio’s vCLAS Ultra catheter achieves ablation temperatures of approximately -170°C enabling highly efficient, single-freeze applications that have been shown to produce effective lesions with greater than 50% reduction in ablation time as demonstrated in pre-clinical models.\n\n\n“The vCLAS Ultra, which was designed to improve energy delivery, navigation, lesion control, and overall procedural workflow efficiency, reflects our team's ability to expeditiously translate feedback from our physician partners into meaningful technological advancement. In parallel, the design incorporates improvements in manufac...