Thermedical Scores Fda Breakthrough Designation For Ablation System To Treat Ventricular Tachycardia

Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart.VT is a leading cause of sudden cardiac death worldwide – an event that kills roughly 325,000 U.S. adults each year. Today, most people with VT are treated with implantable cardioverter defibrillators (ICDs), which monitor the heart rhythm and deliver a strong shock to the heart muscle to correct irregular pacing. However, ICDs don’t halt the disease’s progression, and the repeated shocks can be painful. Patients with persistent VT episodes may get conventional RF ablation therapy, but the procedure is lengthy and only moderately successful.