The US Food and Drug Administration (FDA) has granted 510(k) clearance to Thermedical’s radiofrequency-based ablation system, designed to treat large solid tumors.
The system, which features one or more needles, delivers radiofrequency waves to heat and kill soft cancerous tissue while performing percutaneous, laparoscopic and intraoperative surgical procedures.
The approval was based on substantial preclinical testing carried out using several National Institutes of Health’s small business innovation research (SBIR) grants and a $500,000 grant from the Massachusetts Life Sciences Centre.
Preclinical testing demonstrated the thermal ablation system’s efficacy in treating tissue with a volume range of 5cm to 8cm in diameter, while conventional RF ablation treated a volume up to 2cm in diameter.
National Cancer Institute SBIR director Michael Weingarten said; "The NCI is pleased to have supported the work that led to FDA clearance for this use of radiofrequency waves to treat large tumors."
Thermedical president Dr Michael Curley said the FDA clearance allows the company to carry out a series of clinical trials to evaluate the efficacy of the ablation system for treating large solid tumors, including liver cancer.
"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," Curley said.
"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."
Massachusetts Life Sciences Centre president and CEO Dr Susan Windham-Bannister 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 tumors as well as a multitude of other serious medical conditions."