Thermedical’s SERF Ablation Study Now Underway

The first patient has been treated in Thermedical’s pivotal clinical study evaluating its Saline Enhanced Radiofrequency (SERF) Ablation System with the Durablate Catheter for ventricular tachycardia (VT). The procedure was performed at the Montreal Heart Institute by Katia Dyrda, M.D., a cardiac electrophysiologist and associate professor at the Université de Montréal.

The unidentified patient had undergone four previous ablation procedures and continued to experience fast, dangerous VT episodes. The episodes were triggered by non-ischemic cardiomyopathy following myocarditis, a condition in which the heart muscle becomes weakened—not from blocked arteries, but by inflammation (often from a viral illness) that damages the heart and creates scar tissue capable of triggering dangerous arrhythmias.

Patients with this type of VT often receive an implantable cardioverter defibrillator (ICD). These devices can save lives, but the shocks can be painful, frightening and disruptive, especially for patients who experience them frequently.

During the procedure, SERF ablation enabled Dr. Dyrda to reach deep within the myocardial tissue to eliminate all inducible VT, achieving 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,” she noted. “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 builds on earlier feasibility work showing promising acute results, including the elimination of clinical VT during the procedure 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,” SERF ablation inventor and Thermedical Co-Founder Dr. Michael Curley said. “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.”

VT is an abnormally rapid heart rhythm that is a leading cause of sudden cardiac death worldwide. Sudden cardiac death kills 325,000 U.S. adults annually.¹ Many VT circuits lie deep within the heart muscle, beyond the effective reach of conventional ablation tools. SERF ablation uses a saline-enhanced energy delivery method that enables deeper, more controllable heating of arrhythmogenic tissue. The Durablate catheter is engineered to precisely deliver this energy to treat intramural VT substrates that contribute to repeat procedures, shocks, and ongoing clinical instability. Earlier studies demonstrated high rates of clinical VT elimination, significant reductions in ICD shocks, and the ability to reach tissue that traditional ablation may not effectively treat. These results garnered a $3 million grant from the National Heart Lung and Blood Institute to help fund the pivotal trial.

Thermedical is a privately held medical technology company founded by Dr. Curley and Patrick S. Hamilton, Ph.D., both alumni of the MIT Hyperthermia Center. Dr. Curley, an engineer, also invented the AcuNav Diagnostic Ultrasound Catheter, a technology that dramatically improved visualization during cardiac ablation procedures and helped to accelerate growth of the atrial fibrillation ablation market into a major global category. Building on this legacy of innovation, Thermedical develops advanced thermal-ablation technologies to treat ventricular tachycardia and solid tumors. The company is based in Weston, Mass., and is supported by NIH SBIR grants, the Massachusetts Life Sciences Center, and venture financing. 

Reference
¹ https://www.webmd.com/heart-disease/sudden-cardiac-death