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Adagio Medical Highlights Recent Successful Expanded Access Cases with vCLAS™ System, Including Patients with Premature Ventricular Contractions (PVC)
vCLASTM Used to Treat Patients with No Satisfactory Approved Treatment and/or Failed RF or PFA LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- Adagio Medical
About this update from Adagio Medical Holdings, Inc
[{"type":"text","content":"\nvCLASTM Used to Treat Patients with No Satisfactory Approved Treatment and/or Failed RF or PFA\n\n\n LAGUNA HILLS, Calif.--(BUSINESS WIRE)--\nAdagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the successful completion of 13 ventricular ablation procedures at leading institutions using the Company’s proprietary Ultra-Low Temperature Ablation (ULTA) technology under Expanded Access authorization from the U.S. Food and Drug Administration (FDA). The procedures addressed recurrent, symptomatic ventricular tachycardia (VT) or premature ventricular contractions (PVC) in patients who had previously failed ablations with conventional and/or experimental modalities including radiofrequency (RF), venous ethanol and pulsed field ablation (PFA).\n\n\nThe Expanded Access Program (EAP), also called “Compassionate Use,” is a potential pathway for patients with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. FDA guidelines state that approval for Expanded Access may be appropriate when all the following apply:\n\n\n\nPatient has a serious or immediate life-threatening disease or condition.\n\n\n\nThere is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.\n\n\n\nPatient enrollment in a clinical trial is not possible; and\n\n\n\nPotential patient benefit justifies the potential risks of treatment.\n\n\n\n“Our experience during the FULCRUM-VT pivotal study treating a wide range of patients with VTs due to structural heart disease demonstrated that the combination of catheter stability, lesion depth and the ability to safely navigate around sensitive structures with Adagio’s ULTA technology can be advantageous compared to other ablation technologies,” said Dr. Gregory Supple, Director of Inpatient EP Services at the Hospital of University of Pennsylvania and one of the treating physicians. “Through that experience we recognized that ULTA is a promising option when managing some of our most challenging patients who have failed other ablation approaches, including those with ...