Thermedical Names Leading Electrophysiologists to Oversee Pivotal Study of SERF Ablation for Ventricular Tachycardia
Thermedical®, a developer of advanced thermal-ablation technologies, today announced the members of the independent data safety monitoring board (DSMB), clinical events committee (CEC) and arrhythmia core lab overseeing its pivotal clinical study of the Saline Enhanced Radiofrequency (SERF) Ablation System with the Durablate® Catheter. The study is evaluating SERF ablation in patients with ventricular tachycardia (VT) that continues despite medications and prior ablation procedures.
Thermedical Announces First Patient Treated in Pivotal Clinical Study Evaluating SERF Ablation for Life-Threatening Ventricular Tachycardia
Thermedical®, a developer of advanced thermal-ablation technologies, today announced that the first patient has been treated in a pivotal clinical study evaluating its Saline Enhanced Radiofrequency (SERF) Ablation System with the Durablate® Catheter for ventricular tachycardia (VT) that continues despite medications and multiple prior ablation procedures. The procedure was performed at the Montreal Heart Institute by Katia Dyrda, MD, MSc, FRCPC, a cardiac electrophysiologist and associate professor at the Université de Montréal.
Thermedical Successfully Completes Feasibility Study for Treating Cardiac Arrhythmias Using Pulsed Field Ablation in Combination with SERF Ablation
Thermedical®, a developer of advanced thermal-ablation systems to treat ventricular arrhythmias, announced today that it has completed a feasibility study utilizing Pulsed Field Ablation (PFA) therapy in combination with its SERF Ablation System and Durablate® Catheter for treating ventricular tachycardia (VT). VT is an abnormally rapid heart rhythm that is a leading cause of sudden cardiac death worldwide.
Thermedical Awarded $3 Million NIH Grant to Study Promising Treatment for Ventricular Tachycardia, a Leading Cause of Sudden Cardiac Death
Thermedical®, a developer of thermal-ablation systems to treat ventricular arrhythmias, announced today it has received $3 million in grant funding (1R44HL169112) from the National Heart, Lung, and Blood Institute, a part of the National Institutes of Health, to fund its FDA-approved clinical trial at seven centers in the U.S. and Canada using the SERF Ablation System with the Durablate® Catheter to treat ventricular tachycardia (VT). VT is an abnormally rapid heart rhythm that is a leading cause of sudden cardiac death worldwide. Sudden cardiac death kills 325,000 adults in the U.S. every year1.
Thermedical Announces FDA Approval of Clinical Trial for SERF Ablation to Treat Patients with Ventricular Tachycardia, Leading Cause of Sudden Cardiac Death
Thermedical®, a developer of thermal-ablation systems to treat ventricular arrhythmias, announced today that the U.S. Food & Drug Administration (FDA) has approved an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical® SERF Ablation System with the Durablate® Catheter in people with ventricular tachycardia (VT) resistant to conventional treatment. VT is an abnormally rapid heart rhythm that is a leading cause of sudden cardiac death worldwide.
