FDA Issues Clarification Regarding Use of RF Ablation for Lung Tumors
On Tuesday, the FDA issued a Public Health Notification to clarify for healthcare providers that no radio frequency (RF) ablation devices are specifically approved for use in partial or full ablation of lung tumors. This was sent in follow up to an earlier notice in December 2007, which indicated that a number of deaths have been associated with the use of RF ablation for lung tumors.
RF ablation devices are tools used for general removal of soft tissue by thermal coagulation necrosis. Imaging techniques, such as ultrasound and computed tomography (CT), are used to lead a needle electrode into a cancerous tumor. The abnormal cancer cells are then destroyed by excess heat that is produced by passing high-frequency electrical currents through the electrode.
The FDA has cleared these devices for a number of specific indications, such as complete or partial removal of non-resectable lesions of the liver and mitigation of pain from metastatic injuries of the bone. RF ablation have also been approved generally as a tool to ablate tumors, which could include lung tumors. However, they have not been approved for the specific treatment of partial or complete ablation of lung tumors.
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The FDA has received a number of reports involving deaths and other injuries associated with the use of RF ablation devices for treatment of lung tumors. According to the FDA Public Health Advisory released in December, the regulatory agency indicated that the problems could have been caused by decisions about patient selection for lung tumor ablation, subsequent treatment and the actual technical use of the RF ablation device.
In this week’s clarification notice, the FDA indicates that RF ablation manufacturers have asked that they be allowed to provide training for doctors regarding the use of the devices to ablate lung tumors. However, the FDA indicates that they cannot permit manufacturer sponsored training for a specific indication that has not been approved.
The use of RF ablation for treatment of partial or complete ablation of lung tumors has not been established to be a safe and effective use by the manufacturers. Therefore, FDA regulations prevent the manufacturers from marketing or promoting the devices for this treatment, which would also include specific training programs.
The FDA recommended in December that doctors enroll their patients in an approved clinical trial prior to using RF ablation devices for lung tumor treatments in them and should abstain from using them for unapproved purposes. Although the manufacturer training will not be permitted, the FDA indicated that their statement does not apply to training that may be available from other sources.
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