FDA Panel Backs Device to Treat Brain Tumors
March 17, 2011 -- An expert panel has advised the FDA to approve a new kind of device to treat recurrent glioblastoma, an aggressive and highly fatal kind of brain tumor.
The FDA is not required to follow the recommendations of its advisory panels, though it commonly does.
The NovoTTF-100A System (NovoTTF) is designed to treat tumors by zapping them with an intermediate-frequency electrical field that’s generated by a 6-pound battery pack that a patient carries in a satchel or backpack.
The device has two parts: the battery pack and wires that attach to a sheath of electrodes that are attached to the scalp. The rechargeable batteries must be replaced every three hours. And patients are advised to wear the electrodes for at least 18 hours.
The twelve voting members of the Neurological Devices Advisory Panel were asked to vote on three questions: whether or not they considered the device to be safe; whether they considered it to be effective; and whether or not the benefits of using the device outweighed the risks.
Split Vote on EffectivenessRead More...