PATENTED CRYOANALGESIA IN YOUR HANDS

The iovera° System

iovera° enables you to deliver cryoanalgesia to the site of pain through a patented handheld design. The extreme cold is delivered to the targeted nerve via Smart Tips. Nitrous oxide (N₂O) is the cryogen used to create the extreme cold temperatures at the distal end of the Smart Tips. The iovera° system does not use nitrogen, which can deliver temperatures that cause irreversible nerve damage.

Cartridges containing liquid nitrous oxide are inserted into the Handpiece.

During each treatment cycle, the liquid nitrous oxide flows into the attached Smart Tip, where it expands into a gas. This phase change from liquid to gas causes significant cold temperatures. Nitrous oxide boils at -88^oC, so the coldest temperatures that can be attained when using nitrous oxide is -88^oC. Temperatures lower than -88^oC cannot be reached with this cryogen.

All Smart Tips of the iovera° system are closed-end tips (needles). The nitrous oxide that flows through the needles in the Smart Tip is safely vented through the handpiece as a gas.

Note: No fluid, chemical, or drug is injected into the body during the procedure.

IndicationThe iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue. The iovera° system's "1x90" Smart Tip configuration (indicating one needle which is 90mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve simulator.

Important Safety Information

ContraindicationsThe iovera° system is contraindicated for use in patients with the following:

Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud’s disease, and open and/or infected wounds at or near the treatment site

Potential ComplicationsAs with any surgical treatment that uses needle-based therapy and local anesthesia, there is a potential for site-specific reactions, including, but not limited to:

Ecchymosis, edema, erythema, local pain and/or tenderness, and localized dysesthesia

Proper use of the device as described in the User Guide can help reduce or prevent the following complications:

At the treatment site(s): injury to the skin related to application of cold or heat, hyper- or hypopigmentation, and skin dimpling
Outside the treatment site(s): loss of motor function