Business
Adagio Medical, Inc. Announces Completion of Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Ventricular Tachycardia
LAGUNA HILLS, Calif., October 01, 2025--Adagio Medical Holdings, Inc. (Nasdaq: ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the completion of enrollment of the FULCRUM-VT Pivotal U.S. Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") study evaluating the Company’s vCLASTM Cryoablation System ("vCLAS" or "vCLAS System") for ablation of monomorphic ventricular tachycard
About this update from Adagio Medical Holdings, Inc
[{"type":"text","content":"Study Results are Intended to Support PMA Approval of Adagio’s vCLASTM Cryoablation System Designed to Address the Large Population of Patients with Ventricular Arrhythmias","length":172,"tagName":"p","attribs":{}},{"type":"text","content":"LAGUNA HILLS, Calif., October 01, 2025--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the completion of enrollment of the FULCRUM-VT Pivotal U.S. Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") study evaluating the Company’s vCLASTM Cryoablation System ("vCLAS" or "vCLAS System") for ablation of monomorphic ventricular tachycardia (MMVT). The vCLAS System, which has been granted Breakthrough Device Designation by the FDA, is built on the Company’s proprietary ultra-low temperature cryoablation ("ULTC") technology platform.","length":785,"tagName":"p"},{"type":"text","content":""Adagio’s vCLAS System is the first VT-specific ablation technology to complete enrollment in a pivotal IDE study in the United States," said Dr. Atul Verma, Director of Cardiology at McGill University Health Centre and FULCRUM-VT co-principal investigator. "Our center has had the unique opportunity to participate in both the earlier CRYOCURE-VT study, which supported CE Mark in Europe, and the FDA IDE study in the U.S., and we are firm believers in the many advantages of Adagio’s ULTC as a potential game-changing technology to treat patients with drug-refractory ventricular tachycardia."","length":615,"tagName":"p"},{"type":"text","content":""To date, our options for VT ablation have been limited to catheters and energy sources originally developed to treat atrial arrhythmias, and VT ablation studies were notoriously difficult and slow to enroll," added Dr. Rod Tung, Chief of the Division of Cardiology at Banner University Medical Center and study co-principal investigator. "The fact that the FULCRUM-VT pivotal study completed enrollment in only 11 months speaks volumes to both the market need for a purpose-built VT ablation technology and the positive early experiences with Adagio’s ULTC at the top VT ablation programs that partici...