The US Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to Thermedical for Saline Enhanced Radiofrequency (SERF) ablation system and Durablate catheter.
The device was developed to treat ventricular tachycardia (VT), a condition that causes abnormal heart rate and increases the risks of cardiac arrest.
Currently, implantable cardioverter defibrillators (ICD) are used to monitor the heart rhythm of a patient, suffering from VT. However, this does not cure or stop the progression of the condition.
Thermedical’s SERF ablation system seeks to replace the current standard-of-care treatment for VT by enabling a new form of biological heat transfer. According to the company, the system is 20 times more effective at transferring heat than conventional ablation methods.
Additionally, the Durablate catheter can control the ablation size and treat deeper heart wall tissues, where life-threatening arrhythmias that cause VT are usually located.
Thermedical board of directors member Roy Tanaka said: “Today, an estimated one million people who develop or are likely to develop VT annually have limited options for effective treatment and often suffer a very poor quality of life.
“Thermedical’s ablation technology will be transformational in clinical electrophysiology. It offers the potential for an entirely new therapy that could replace the standard-of-care treatment for VT.”
Currently, the SERF VT Early Feasibility Study (EFS) is underway at the US and Canada to assess the safety and effectiveness of the Durablate catheter to treat the heart disease.
SERF VT EFS principal investigator William G Stevenson said: “Preliminary results are encouraging. I am optimistic that this therapy will offer new hope for patients with VT who have failed all other therapeutic options.”