Device designed to help the large population of patients suffering from ventricular tachycardia receives FDA designation

New device targets ventricular tachycardia: ©Uladzislau - stock.adobe.com

Adagio Medical Holdings Inc. (Nasdaq: ADGM) announced that its vCLAS Cryoablation System has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), marking a major step forward in the company’s efforts to bring its next-generation cardiac ablation technology to U.S. patients suffering from life-threatening heart rhythm disorders.

The FDA granted the designation for Adagio’s vCLAS Cryoablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease. The system uses Adagio’s proprietary Ultra-Low Temperature Cryoablation (ULTC) technology and is currently under investigation in the U.S. through the FULCRUM-VT study.

“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. “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 FDA’s Breakthrough Device Program is designed to expedite the development and review of medical technologies that may provide more effective treatment or diagnosis of serious conditions. Devices must demonstrate the potential to significantly improve patient outcomes and meet one or more additional criteria, such as offering a breakthrough technology or addressing an unmet medical need.

Under this designation, Adagio will benefit from enhanced interaction with the FDA and priority review during the premarket approval process for the vCLAS System.

Ventricular tachycardia is a fast, abnormal heart rhythm that originates in the ventricles and can severely reduce blood flow, sometimes becoming life-threatening if not treated effectively. Catheter ablation is a key therapeutic option for patients who do not respond to medications.

The FULCRUM-VT study, currently enrolling 206 patients with both ischemic and non-ischemic structural heart disease, is evaluating the safety and effectiveness of the vCLAS system. The data from this study will support Adagio’s premarket approval application and could lead to the system’s commercial availability in the U.S.

While the vCLAS Cryoablation System is already available for treating monomorphic VT in parts of Europe and other international markets, it remains investigational in the United States.

“We are encouraged that, based in part on the strength of the clinical data from our European CRYOCURE-VT study, the FDA has determined that vCLAS qualifies as a Breakthrough Device,” Usen added. “We look forward to working collaboratively with the agency to make the vCLAS System available to U.S. physicians and patients as expeditiously as possible.”