Thermedical today said it received approval from Health Canada and the FDA for its degassed saline for use in its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate catheter.
The catheter is currently being studied for the treatment of ventricular tachycardia. SERF ablation using the Durablate catheter is a treatment option for patients with ventricular arrhythmias that are resistant to antiarrhythmic drugs or standard ablation procedures.
“Although ventricular arrhythmias cannot always be completely cured, the new SERF irrigated needle ablation technique with degassed saline solution represents a great advance for patients with extensive diseases, and for whom the next treatment options would be a heart transplant or mechanical heart,” said Dr. Katia Dyrda, associate professor of medicine, electrophysiology training program director at the Montreal Heart Institute. “Moreover, this innovative procedure has the power to greatly improve the quality of life for patients, and I am extremely happy to work in a hospital that makes breakthrough treatments like this available to patients.”
Degassed saline is able to reach abnormal muscle fibers deep within the heart wall has been unable to reach, which is where life-threatening arrhythmias are often located.
“We hope to one day eliminate or reduce VT episodes in patients and, as a result, significantly improve their quality of life,” co-founder and CEO Michael Curley said in a news release. ““We are extremely encouraged by Dr. Dyrda and her success in performing ablation using our technology, and we are honored that she is the first in the world to perform it at MHI using our new degassed saline. Further, gas released during any form of ablation therapy is a clinical concern for potential procedural-related stroke. We believe that the use of degassed saline can similarly reduce the amount of gas produced during other ablation procedures such as ablation for atrial fibrillation. We will work to demonstrate the clinical utility of degassed saline for all forms of ablation therapy, and we hope to show that it has widespread ability to reduce gas generated during ablations.”