Adagio Medical submits FDA application for ventricular tachycardia ablation system

Adagio Medical Holdings Inc. announced it has submitted a Premarket Approval application to the U.S. Food and Drug Administration for its vCLAS Ventricular Ablation System, designed to treat patients with drug-refractory, recurrent, sustained monomorphic ventricular tachycardia.

The company said the catheter-based system is intended for patients with ischemic or non-ischemic structural heart disease and is built on its proprietary Ultra-Low Temperature Ablation technology.

The FDA submission is supported by data from the FULCRUM-VT pivotal investigational device exemption trial, a single-arm study involving 209 patients treated at 20 electrophysiology centers.

According to Adagio, the study achieved a 97.4% acute clinical success rate. At six months, 84.3% of patients remained free from implantable cardioverter-defibrillator shocks, while major adverse events occurred in 2.4% of patients. The company also reported a 78% reduction or elimination in the use of anti-arrhythmic drugs.

Adagio said the system demonstrated similar effectiveness in both ischemic and non-ischemic cardiomyopathy patients, an area the company described as a significant unmet need in ventricular tachycardia treatment.

“The submission of our PMA application is a defining moment for Adagio Medical and, more importantly, for the hundreds of thousands of patients suffering from ventricular tachycardia who currently have no purpose-built solution,” CEO Todd Usen said in a statement.

Usen said the company believes its ULTA technology offers a safer and more consistent approach to VT ablation while potentially broadening access to treatment through an endocardial-only procedure.

Ventricular tachycardia is a potentially life-threatening heart rhythm disorder that can increase the risk of sudden cardiac arrest. Current treatment options include anti-arrhythmic medications, implantable cardioverter-defibrillators and catheter ablation procedures.

Adagio Medical develops catheter ablation technologies for cardiac arrhythmias and is focused on commercializing devices that use ultra-low temperature energy to create durable lesions in cardiac tissue.