Adagio Medical Holdings (NASDAQ: ADGM) has announced the submission of its Premarket Approval (PMA) application to the FDA for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease.
According to Adagio, the PMA submission is supported by the FULCRUM-VT pivotal IDE trial, a single-arm study that enrolled 209 patients across 20 leading electrophysiology centers.
In a statement, Todd Usen, CEO of Adagio, commented, “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.”
Mr. Usen added, “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.”
