||stimulator, low electric field, tumor treatment|
||Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.
||The device consists of sets of contact electrodes that are applied to the patient's shaved head, a connecting cable and a belt mounted control box and signal generator. The sets are 3 electrodes each adn there can be 2 or 3 sets used at a time.
||This is a battery powered device. Electric fields that alter thier polarity at a frequency near 200kHz with an intensity near 0.7 V/cm are continuosly applied to the target tumor 24 hours a day for 6 months at a time. This electric field creates, during mitosis process, disruption of the microtubules due to the focussing effect of the narrow neck of the dividing cell.
||The device is currently used only on the human head.
Office of Device Evaluation
Division of Neurological and Physical Medicine Devices
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible