Adagio Medical (Nasdaq:ADGM) announced today that it received FDA breakthrough device designation for its vCLAS cryoablation system.
The Laguna Hills, California-based company based 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.
Adagio currently has vCLAS under evaluation in an FDA investigational device exemption (IDE) study called FULCRUM-VT. Earlier this year, the company executed a restructuring effort to prioritize FULCRUM-VT. With layoffs included, the restructuring also centered focus on a new product design optimization program.
The FDA breakthrough nod provides priority review and interactive communication during the premarket review phase.
“Receiving breakthrough device designation is an important milestone for Adagio, validating our proprietary vCLAS cryoablation system with our ULTC technology as a potentially unique solution for the large, underserved population of patients suffering from ventricular tachycardia,” said Todd Usen, CEO of Adagio. “Our team has been working hard to bring this transformational technology to patients, and we are thrilled to be the only technology to be granted breakthrough device designation for endocardial treatment of both ischemic and nonischemic structural heart disease patients with sustained monomorphic VT.”
The company currently markets vCLAS for treating monomorphic VT in Europe and other select geographies. It remains investigational in the U.S.
