RadioTherapeutics' RF 2000
This article was originally published in The Gray Sheet
Executive Summary
Radiofrequency ablation system is cleared by FDA for treatment of nonresectable liver lesions April 7 through the agency's real-time 510(k) review process. The system initially was approved in 1997 for the general indication of soft tissue necrosis. FDA had cited the company in a May 14, 1998 warning letter for stating in a press release that clinical studies of the product demonstrated "its potential to address the significant need for an alternative or complementary treatment for liver tumors that cannot be removed surgically." Boston Scientific distributes the system in the U.S. for radiological applications. RadioTherapeutics will promote the new indication. The device is targeted at the 90% of the roughly 135,000 patients diagnosed with primary or metastatic liver tumors in the U.S. annually who are not candidates for surgery. The company estimates the worldwide patient population at 2 mil., due in large part to the prevalence of hepatitis C infection in Asia