Adagio Medical (Nasdaq:ADGM) announced today that it completed enrollment for its FULCRUM-VT pivotal FDA IDE study.
FULCRUM-VT evaluates the company’s vCLAS cryoablation system for the ablation of monomorphic ventricular tachycardia (MMVT).
The Laguna Hills, California–based company built its vCLAS cryoablation catheter on its proprietary ultra-low cryoablation technology (ULCT). It aims to address the challenges of ventricular tachycardia (VT) ablations, comprising part of the Adagio VT cryoablation system. The system’s features make it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with multiple VT etiologies.
vCLAS picked up FDA breakthrough device designation earlier this year. Prior to that, the company also executed a restructuring effort to prioritize FULCRUM-VT. With layoffs included, the restructuring also centered focus on a new product design optimization program.
FULCRUM-VT evaluates the safety and effectiveness of vCLAS in the ablation treatment of scar-mediated sustained MMVT in patients with ischemic and non-ischemic structural heart disease. It has a primary efficacy endpoint of six-month freedom from recurrent MMVT in the absence of new or increased dose of pre-ablation antiarrhythmic drugs (AAD) for VT management.
The study enrolled 208 patients across 20 centers in the U.S. and Canada. Adagio plans to use results to support an FDA premarket approval (PMA) application.
“I would like to thank the FULCRUM-VT investigators and research staff who have done an outstanding job working with our team over the last several months to achieve this critical milestone,” said Todd Usen, CEO of Adagio Medical. “We are also grateful to the FDA for our collaborative relationship. We are excited for the potential to bring our ULTC technology to the underserved population of VT patients and we anticipate completion of the PMA process for the vCLAS system by year-end 2026, consistent with previous guidance.”
