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Stock impact report

Adagio Medical, Inc. Announces Completion of Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Ventricular Tachycardia

Adagio Medical Holdings, Inc (ADGM) 
Company Research Source: Business Wire
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 LAGUNA HILLS, Calif.--(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.“Adagio’s vCLAS System is the first VT-specific ablation technology to complete enrollment in a pivotal IDE study in the Unite Show less Read more
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