Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), 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 Durablate® catheter. The intent of the FDA Breakthrough Devices Program is to help patients receive more timely access to technologies that provide for a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Ventricular tachycardia, which is an abnormally rapid heart rhythm, is a leading cause of sudden cardiac death worldwide according to the company. Thermedical is a privately held company founded by Massachusetts Institute of Technology (MIT) Hyperthermia Center alumni, Michael G. Curley, Ph.D. and Patrick S. Hamilton, Ph.D., based in Waltham, Mass. Under a Massachusetts Life Sciences Center Small Business Matching Grant (SBMG) Award, multiple NIH* Small Business Innovation Research (SBIR) Grants, and Series A venture funding, the company has developed thermal-ablation systems to treat VT and solid tumors.