FDA Alert: RF Ablation Devices to treat lung tumors

By Austin Kirk
Posted December 16, 2007

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Last week an FDA alert was issued regarding problems associated with use of RF ablation devices to treat individuals with lung tumors.  There have been a number of deaths associated with the use of radio frequency (RF) devices during lung tumor ablation, and the FDA advised healthcare professionals to use caution and adhere strictly to the instructions in the Operating Manual.

>>FDA ALERT: RF Lung Tumor Ablation

Generally, the term “ablation” involves the removal of material from the surface of an object by vaporization, chipping or other erosive processes.  Radio frequency ablation devices are used for removal of soft tissue by thermal coagulation necrosis.   

Radio frequency ablation (also referred to as RFA), is often performed as an outpatient procedure with use of general anesthesia or conscious sedation.  A small needle-electrode is inserted directly into the tumor, and during 10-15 minutes of active ablation, the procedure causes the tumor cells to die, replaced by scar tissue which shrinks during the subsequent months.

The FDA indicates that the reported deaths associated with the use of the RF ablation devices, could have also been impacted by decisions about patient selection for lung tumor ablation, subsequent treatment and the actual technical use of the RF ablation device.

The RF ablation devices have not been specifically approved for lung tumor ablation.  Therefore, the companies that manufacture the ablation devices are not allowed to market the devices for lung tumor ablation or promote their safety and effectiveness in training programs.  The FDA has not been provided with clinical data establishing that RF ablation devices are safe or effective for treatment of patients with lung tumors.

Although they are not specifically approved for lung tumor ablation, because the RF ablation devices have been approved for general indications, doctors are free to use them for unapproved purposes.  The FDA indicates that if doctors plan to use RF ablation to treat lung tumors, they should consider having the patient enroll in an approved clinical study.