Adagio completes enrollment in FULCRUM-VT pivotal IDE study for vCLAS cryoablation system

Adagio Medical Holdings, Inc.

Enrolled 208 patients across 20 U.S. and Canadian centers for vCLAS System to treat monomorphic ventricular tachycardia.
Study results support PMA application; FDA granted Breakthrough Device Designation for vCLAS.
Primary efficacy endpoint: six-month freedom from recurrent MMVT without new/increased antiarrhythmic drugs.
Company anticipates FDA PMA approval by year-end 2026, consistent with prior guidance.
vCLAS System commercially available in Europe for MMVT; limited to investigational use in the U.S.

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