FDA: Deaths Related to Radio Frequency Ablation
Technical use of ablation devices may have led to fatalities in patients with lung tumors
THURSDAY, Dec. 13 (HealthDay News) -- Use of radio frequency (RF) ablation devices in the treatment of lung tumors has resulted in some patient deaths, according to a public health notification released by the U.S. Food and Drug Administration this week.
The FDA reports that several factors may have led to the fatalities, including selection of patients, subsequent treatments, and placement and operation of RF devices.
While the FDA has cleared many RF ablation devices for indications such as general ablation of soft tissue, ablation of non-resectable liver lesions, and ablation of bony metastatic lesions for palliation of pain, the devices have not been cleared specifically for ablation of lung tumors. Manufacturers of ablation devices thus may not market the devices for the purpose of lung tumor ablation until clinical data establishing their safety and efficacy for this indication is submitted to and approved by the FDA.
The FDA recommends that providers exercise special caution when operating RF ablation devices, and for those who wish to treat patients with lung tumors with an RF ablation device to consider enrolling them in an approved clinical study. The FDA also states, "If you suspect that a reportable adverse event was related to the use of an RF ablation device, you should follow the reporting procedure established by your facility."