Adagio Medical announced today that it picked up FDA investigational device exemption (IDE) for a study of its VT cryoablation system.
The Laguna Hills, California-based company also completed the first commercial procedures in Europe following CE mark approval.
Adagio Medical designed its VT system with the vCLAS cryoablation catheter based on its proprietary ultra-low cryoablation technology. It aims to address the challenges of ventricular tachycardia (VT) ablations. The system’s features make it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with multiple VT etiologies.
In the U.S., the company completed enrollment in its FULCRUM-VT early feasibility study. Adagio plans to present initial data at the Heart Rhythm Society sessions in Boston on May 19. The company said that data, with its Cryocure-VT dataset, supported FDA approval to convert FULCRUM-VT to the pivotal phase.
The expanded, single-arm study plans to enroll 206 patients with monomorphic VT due to structural heart disease of both ischemic and non-ischemic origin.
In Europe, Dr. Roland Tilz of the University Clinic Schleswig-Holstein (Germany) performed the first commercial cases. Tilz says Adagio Medical’s technology offers a promising approach in ablation, saying it could be a “game-changer” in time-consuming large-area ablations.
“We greatly appreciate the partnership from the electrophysiology community in the U.S. and EU as we expand our proprietary ULTC platform to the benefit of the sizeable, yet underserved population of patients with drug-refractory VTs,” said Olav Bergheim, president and CEO of Adagio. “We believe we have a strong momentum in both commercial launch and clinical trials program, and look forward to sharing our progress on both fronts.”
