FDA Clarifies Status of RF Ablation of Lung Tumors

The FDA has issued a clarification of a public health notification it sent in December 2007 following the reports of death and serious injuries associated with the use of radio-frequency (RF) ablation devices in the treatment of lung tumors.

In the clarification, the agency says it has not cleared any RF ablation devices for the specific treatment indication of partial or complete ablation of lung tumors. However, based on bench-testing data or animal testing, it has cleared such devices for the general indication of soft tissue cutting, coagulation and ablation by thermal coagulation necrosis.

“Under this general indication, RF ablation can be used as a tool to ablate tumors, including lung tumors,” the FDA said.

SOURCE: FDANEWS