Non-pharmacological pain relief using innovative technology

About iovera°

Indication

The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can 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.

What is the iovera° treatment?

The iovera° treatment uses the body’s natural response to cold to treat peripheral nerves and immediately reduce pain – without the use of drugs. Treated nerves are temporarily stopped from sending pain signals, followed by a restoration of function.
It is important to note that the iovera° therapy does not treat the underlying cause of the pain. Timely remediation is necessary to address and treat the cause of pain.

How does iovera° treatment work?

The iovera° treatment works by applying targeted cold to a peripheral nerve. A precise cold zone is formed under the skin – cold enough to immediately prevent the nerve from sending pain signals without causing damage to surrounding structures. The effect on the nerve is temporary, providing pain relief until the nerve regenerates and function is restored.

The iovera° treatment does not include injection of any substance, opioid, or any other drug. The effect of this treatment is immediate and can last up to 90 days.1



The iovera° system

iovera° enables the treating physician 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°C, so the coldest temperatures that can be attained when using nitrous oxide is -88°C. Temperatures lower than -88°C 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.


Important safety information

The iovera° system should not be used in people with the following conditions:

  • Cryoglobulinaemia, paroxysmal cold haemoglobinuria, cold urticaria, Raynaud’s disease, and open and/or infected wounds at or near the treatment site

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

  • Ecchymosis, oedema, erythema, local pain and/or tenderness, and localized dysaesthesia

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

Reference
1. Radnovich R, et al. Osteoarthritis Cartilage. 2017;25(8):1247-1256.