NON-OPIOID PAIN RELIEF USING INNOVATIVE TECHNOLOGY

About iovera°

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 for a period of time, 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

  • Treatment

    I. Treatment

    A cold zone is created, lowering the temperature to below -20°C.

  • Degeneration

    II. Degeneration

    Cold zone causes degeneration of the axon and myelin sheath, temporarily blocking nerve signals.

  • Regeneration

    III. Regeneration

    Post treatment, the axon regenerates at the rate of about 1 to 2 mm per day.

  • Reinnervation

    IV. Reinnervation

    The axon and myelin sheath are fully regenerated and nerve signaling is restored.

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REFERENCE

  1. Radnovich R, Scott D, Patel AT, et al. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017;25(8):1247-1256.

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