A Medical Device Daily

Thermedical (Sommerville, Massachusetts) a privately held company developing a proprietary ablation therapy for the treatment of cancer, reported that it has received a $3.6 million Competing Phase 2 Renewal Grant from the National Heart, Lung and Blood Institute (NHLBI).

The three-year grant will fund continued development and testing of the company's Saline Enhanced Radiofrequency Ablation (SERF) system, which is designed for use in ablation treatment for ventricular tachycardia (VT).

"The funding from the National Heart Lung and Blood Institute will allow us to assess whether SERF Ablation is useful for treating the arrhythmogenic tracks that are left within infarct scars following a myocardial infarction, or heart attack," said Michael Curley, PhD, founder of Thermedical and principal investigator on the project. "Physicians feel these tracks are critical to the occurrence of VT and can lead to sudden cardiac death."

In Thermedical's previously funded Phase 2 grant, the company documented for the first time that remnant healthy myocardium within infarct scars (the channels thought responsible for a portion of the VT circuit) has been ablated throughout the scar's depth. The practical implication of these results is that SERF ablation should eliminate the VT circuits associated with the infarct scar.

SERF ablation uses radio frequency (RF) electrical energy to overheat, and as a result, kill myocardial tissue. The energy is delivered by a catheter-delivered needle that simultaneously injects warm saline into the tissue. The saline alters the physics of energy delivery through the tissue, potentially allowing treatment of much larger volumes than can presently be treated using RF alone.

The proceeds from the grant will be used to gather the data needed to apply for an FDA Investigational Device Exemption for clinical trials for ablation of myocardial infarct scars.