Curaway

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 ID16936666558108

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information