Waltham, Mass.-based medical device company Thermedical landed FDA clearance for its new ablation system, designed to coagulate and ablate soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
The regulatory win allows Thermedical to market its ablation systems in the U.S. and to investigate the impact of the technology in treating large, solid tumors in clinical testing.*
"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," president Dr. Michael Curley said in prepared remarks. "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."
Conventional radiofrequency thermal ablation, in which needles or catheters deliver radiofrequency energy to destroy tissue, might overheat tissue near the applicator. Thermedical’s technology could optimize heat transfer and offers the potential to extend treatment to larger volumes of tissue, according to the press release.
The device maker has had the support of several large institutions in developing its ablation technology.
Pre-clinical testing was supported by the National Institutes of Health’s Small Business Innovation Research Grants and conducted at the University of Colorado Denver, the University of Cincinnati Medical Center, Ohio, and the University of Louisville Medical Center, KY.
The Massachusetts Life Sciences Center in 2010 awarded Thermedical a $500,000 Small Business Matching Grant under Governor Deval Patrick’s 10-year, $1 billion Life Sciences Initiative.
Correction, November 1, 2012: This article mistakenly stated that the new ablation system was cleared with indication to treat large, solid tumors. The clearance is for soft tissue and the company has can begin investigation ablation on large, solid tumors.