FDA and Health Canada Approve Thermedical’s Degassed Saline to Help Reduce Risk of Stroke

MONTREAL and WALTHAM, Mass., June 16, 2020 (GLOBE NEWSWIRE) -- The Montreal Heart Institute (MHI) and Thermedical^®, a developer of thermal-ablation systems to treat ventricular arrhythmias, today announced the first ablation performed using the groundbreaking Durablate® retractable needle catheter and degassed saline, which together eliminate over 98% of the air bubbles that can lead to stroke.

Health Canada and the U.S. Food & Drug Administration (FDA) approved Thermedical’s degassed saline for use with its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate catheter, currently being studied for the treatment of ventricular tachycardia (VT), a leading cause of sudden cardiac death worldwide.

“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, 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,” continued Dr. Dyrda.

SERF ablation with the Durablate catheter is an effective treatment option for patients with ventricular arrhythmias that are resistant to antiarrhythmic drugs or standard ablation procedures. The reason is that Thermedical’s SERF ablation using degassed saline can reach abnormal muscle fibers deep in the heart wall where standard ablation cannot reach and where life-threatening arrhythmias are often located. In addition, Thermedical’s ablation system with degassed saline reduces air bubble volume generated during VT ablation by greater than 98%. Clinical research suggests that air bubbles may contribute to procedure-related strokes.

Dr. Dyrda, who is leading Montreal Heart Institute’s participation in the SERF VT Ablation study, was the second practitioner to perform an ablation using the new technology in Canada, and the first to perform this intervention using degassed saline. To date, 11 patients have benefitted from the SERF ablation procedure at MHI and three were treated with the new degassed saline. In total, there have been 21 patients treated with SERF ablation in Canada, and five treatments also included degassed saline.

“We hope to one day eliminate or reduce VT episodes in patients and, as a result, significantly improve their quality of life,” said Michael Curley, Ph.D., FHRS, co-founder and chief executive officer of Thermedical. “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,” continued Dr. Curley. “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.”

About Montreal Heart Institute
Founded in 1954, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention. It houses the largest research center in Canada, the largest cardiovascular prevention center in the country, and a cardiovascular genetics center. The Institute is affiliated with the University of Montreal and has more than 2,000 employees, including 245 doctors and more than 85 researchers.

About Thermedical
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 ventricular tachycardia (VT) and solid tumors. The Saline Enhanced Radiofrequency (SERF) VT Ablation Early Feasibility Study (EFS) is underway at six centers in the U.S. and Canada. For more information, visit www.thermedical.com.

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MHI
Camille Turbide
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Thermedical
Amy Cook
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*Research reported in this publication was supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number R44HL132746 and R44HL63535. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.