FDA 510(k) Clearance For Thermedical™ RF Ablation System For Larger Tissue Volumes

In short

Thermedical™, a medical equipment company developing new tissue-ablation therapies, has received U.S. FDA clearance to market its innovative technology for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Background

Radiofrequency (RF) thermal ablation, in which one or more needles or catheters deliver RF waves to heat and kill tissue, is already used to treat small liver tumors. However, conventional RF may in some cases overheat tissue near the applicator and has had limited success in treating larger tumors of the size commonly found when liver cancer is first diagnosed.

Thermedical says its innovative technology optimises heat transfer and offers the potential to extend treatment to larger volumes of tissue. The company’s preclinical testing demonstrates that while conventional RF ablation can treat a volume up to two centimeters in diameter, the Thermedical ablation system was able to successfully and quickly heat tissue volumes of five-to-eight centimeters in diameter. Clinical testing is planned to investigate the impact of the Thermedical technology in subjects with large tumors.

FDA clearance of the Thermedical Ablation system was based on substantial preclinical testing carried out under multiple National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Grants at the University of Colorado Denver, the University of Cincinnati Medical Center, Ohio, and the University of Louisville Medical Center, KY.

Company comments

“Receiving FDA clearance is a significant milestone for Thermedical as it will facilitate our plans to carry out a series of clinical trials to evaluate the efficacy of our system for treating large, solid tumors, including liver cancer,” said Michael G. Curley, Ph.D., president of Thermedical. “We are in active discussions with leading medical centers in the United States to begin these clinical trials, and we look forward to reporting our results in the future.

“Based on our system’s design features, such as the demonstrated ability to rapidly treat large volumes of tissue using a single needle, we believe the Thermedical system has the potential to treat large tumors, offering positive clinical outcomes,” continued Dr. Curley.

Source: Thermedical