LAGUNA HILLS, Calif. — Adagio Medical Holdings Inc. has submitted a premarket approval application to the U.S. Food and Drug Administration for its vCLAS Ventricular Ablation System, a catheter ablation technology designed to treat ventricular tachycardia.
The company is seeking approval for use of the system in patients with drug-refractory, recurrent, sustained monomorphic ventricular tachycardia who have ischemic or non-ischemic structural heart disease.
Adagio said the application is supported by data from the FULCRUM-VT pivotal IDE trial, a single-arm study that enrolled 209 patients at 20 electrophysiology centers. The company said the trial achieved 97.4% acute clinical success and showed 84.3% freedom from ICD shock at six months.
The trial also reported a 2.4% rate of major adverse events and a 78% reduction or elimination of anti-arrhythmic drug use. Adagio said the vCLAS system demonstrated similar clinical effectiveness in patients with ischemic and non-ischemic cardiomyopathy.
The company said the submission marks the first premarket approval application for a ventricular tachycardia ablation system purpose-built for that condition. The device previously received FDA Breakthrough Device designation.
“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,” said Todd Usen, Chief Executive Officer of Adagio Medical. “We believe FULCRUM-VT demonstrated that Adagio’s proprietary ULTA is not just a different approach to VT ablation – it is a fundamentally better solution, which achieved compelling outcomes across the metrics that matter most to physicians and patients: safety, freedom from ICD shock, reduction in AAD use, and consistent results across the broadest patient population ever studied in a VT ablation trial. Our endocardial-only approach has the potential to democratize VT ablation for electrophysiologists and offers physicians a purpose-built tool capable of treating every eligible VT patient — ischemic and non-ischemic alike — without compromise. We look forward to working closely with the FDA through the review process and are energized by the possibility of bringing this technology to a broad population of patients suffering from VT.”
