WESTON, Mass.–(BUSINESS WIRE)–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 […]
Tag: Thermedical
Thermedical Announces FDA Approval of Clinical Trial for SERF Ablation to Treat Patients with Ventricular Tachycardia, Leading Cause of Sudden Cardiac Death
WALTHAM, Mass.–(BUSINESS WIRE)–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 […]
Thermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation
WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and […]
Thermedical Announces SERF VT Study Presented as Part of HRS 2020 Science Late-Breaking Clinical Trial Sessions
Results Suggest Highly Effective Method to Treat Ventricular Tachycardia, a Leading Cause of Sudden Cardiac Death WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of thermal-ablation systems to treat ventricular tachycardia (VT), announced that results from a First-in-Human Early Feasibility Study (EFS) using […]
Thermedical Announces FDA Investigational Device Exemption Approval to Begin US Clinical Study of Durablate Catheter for Treatment of Ventricular Tachycardia
WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical® announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for the Early Feasibility Study (EFS) of the groundbreaking Durablate™ ablation catheter. The single-arm, observational study is designed to […]