Thermedical has obtained 510(k) clearance for its radiofrequency-based thermal ablation system, designed for treating large volumes of solid tumors, from the US Food and Drug Administration (FDA).
Featuring a single or more needles, the system 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 $500,000 grant from the Massachusetts Life Sciences Center.
The preclinical testing demonstrated that the ablation system can treat soft tissues of volumes ranging from five-to-eight centimeters in diameter, while conventional RF ablation treating volumes up to two centimeters in diameter.
Thermedical president 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 added.