Device typeIrreversible electroporation system: A mobile assembly of devices designed to apply a series of microsecond electrical pulses to tissue to produce irreversible cell membrane electroporation, a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death. The system typically consists of both a mains electricity (AC-powered) computerized current generator with user interface and controls (e.g., foot-switch), and additional necessary components such as electrocardiogram (ECG) trigger monitor and sterile needle-like electrode probes. It is intended for the nonthermal surgical ablation of soft-tissues (e.g., tumours, endothelium).
FDA categoryLow energy direct current thermal ablation system
Device IDH787204001030
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Unsafe
Length15 Centimeter