Thermedical receives FDA 510(k) clearance for new ablation system


The US Food and Drug Administration (FDA) has given clearance to Thermedical to market its innovative technology for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

“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 tumours, including liver cancer,” said Michael G Curley, president of Thermedical. “We are in active discussions with leading medical centres in the USA 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 tumours, offering positive clinical outcomes,” added Curley.

Radiofrequency thermal ablation has already been used to treat small liver tumours. However, conventional radiofrequency may, in some cases, overheat tissue near the applicator and has had limited success in treating larger tumours of the size commonly found when liver cancer is first diagnosed.
The new ablation system, according to Thermedical, optimises heat transfer and offers the potential to extend treatment to larger volumes of tissue. The company’s pre-clinical testing demonstrates that, while conventional radiofrequency ablation can treat a volume up to 2cm in diameter, the Thermedical ablation system was able to successfully and quickly heat tissue volumes of 5–8cm in diameter. Clinical testing has been planned to investigate the impact of the ablation technology in subjects with large tumours.

Thermedical was awarded a US$500,000 Small Business Matching Grant in 2010 by the Massachusetts Life Sciences Centre (MLSC). Susan Windham-Bannister, president and CEO of MLSC, said: “We are glad to see Thermedical’s progress, and commend their ongoing commitment to clinical trials to further study this breakthrough technology for the treatment of solid malignant tumours as well as a multitude of other serious medical conditions. Our Small Business Matching Grant Program is intended for just this purpose—to support companies like Thermedical that are working on the commercialisation of innovative technologies.”

“The National Cancer Institute (NCI) is pleased to have supported the work that led to FDA clearance for this use of radiofrequency waves to treat large tumours,” said Michael Weingarten, NCI SBIR director.