WESTON, Mass. — Thermedical®, a developer of advanced thermal ablation technologies, said 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 persists 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.
The first patient treated in the study had previously undergone four ablation procedures and continued to experience fast, dangerous VT episodes. The condition was caused by non-ischemic cardiomyopathy following myocarditis, in which inflammation weakens the heart muscle and creates scar tissue capable of triggering life-threatening arrhythmias.
Patients with this form of VT often rely on implantable cardioverter defibrillators (ICDs) to prevent sudden cardiac death. While effective, ICD shocks can be painful and distressing, particularly for patients who experience them frequently.
During the procedure, SERF ablation enabled deep penetration into myocardial tissue, allowing physicians to eliminate all inducible VT and achieve immediate acute success. “This patient had been living with dangerous heart rhythms that kept returning despite several previous ablations, as the circuits were very difficult to reach,” Dyrda said. “Using the SERF technique, we were able to stop the abnormal rhythm during the procedure completely. If these results hold over time, SERF could change what we can offer patients who are still living with the fear of another shock.”
The SERF-VT Ablation Study (ClinicalTrials.gov ID: NCT05337241) builds on earlier feasibility studies that demonstrated promising acute outcomes, including elimination of clinical VT during procedures and reductions in ICD shocks during follow-up.
“Initiating this pivotal study is a significant step forward for Thermedical and reflects the strong progress our team has made in developing a differentiated VT therapy,” said Michael Curley, Ph.D., inventor of SERF ablation and co-founder and CEO of Thermedical. “The transition from feasibility work into a pivotal trial is a major milestone for any company, and we are committed to executing this study with the rigor required for a PMA submission.”
“SERF ablation represents a platform with the potential to expand what electrophysiologists can offer, and we are focused on building the clinical and operational foundation needed to bring this technology to market,” Curley added.
