3033-001 Revision D January 2018
©NxThera 2018
Page 9 of 90
1.4
Product Description
The Rezūm generator is designed to heat the RF coil within the hand-held Delivery Device
rapidly. The device uses radio frequency (RF) energy to heat water into vapor outside the body.
The vapor is injected into the tissue and rapidly disperses through the interstitial spaces
between the tissue cells. The vapor begins to cool and condenses immediately on contact with
tissue. The stored heat energy is released, gently denaturing the cell membranes and causing
instantaneous cell death.
The denatured tissue is absorbed by the body over time. The vapor condensation process also
causes a rapid collapse of blood vessels in the ablation treatment zone, resulting in a bloodless
procedure.
The generator rapidly heats and converts sterile water into nearly pure or “dry vapor” at slightly
above 100°C. The generator delivers this thermal energy in the form of dry vapor at
temperatures through precise vapor emitter openings at the tip of the Vapor Emitter Needle.
The rate and time over which the thermal energy in the form of vapor is delivered is monitored
and regulated by the generator.