FDA Approves Thermedical’s Clinical Trial to Evaluate SERF Ablation System

The FDA has given the go-ahead to Thermedical for a clinical trial investigating the efficacy and safety of its SERF Ablation system when combined with the Durablate catheter in patients with ventricular tachycardia, an abnormally rapid heart rhythm that can lead to sudden cardiac death.

The system delivers radiofrequency energy and heated saline to a targeted location in the body for local thermal coagulation and ablation of soft tissue.

The FDA granted the technology 510(k) clearance in 2012 for ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures. However, the SERF Ablation system is investigational because it uses saline-enhanced radiofrequency.

The Durablate catheter is also in the investigational stage. It has a 25-gauge retractable needle that penetrates the myocardium, enabling treatment from within the scar.

In a clinical study, 31 out of 32 participants no longer had ventricular tachycardia at the end of the treatment, the company said.