How it works

History of CryoanalgesiaCold has been used to relieve pain since the days of Hippocrates in ancient Greece. Modern cold therapy, or cryotherapy, has been around since the 1950s and is a trusted technology for treating pain.

  • 400 BC

    Hippocrates uses cold to relieve swelling, bleeding, and pain.

  • 1050

    An Anglo-Saxon monk uses cold as a local anesthetic.

  • 1899

    Campbell White is the first to employ refrigerants for medical use.

  • 1961

    Dr Irving S. Cooper develops device with hollow tube to deliver pressurized nitrogen and achieve -190°C at the tip.

  • 1967

    Setrag Zacarian introduces a hand-held self-pressurized cryogen spray device.

  • 1976

    Lloyd et al proposes that cryoanalgesia is superior to other methods of peripheral nerve destruction.

  • 2013

    The iovera° treatment system is launched. It delivers targeted cold to a peripheral nerve, immediately relieving pain.

Cryoanalgesia (also known as cryoneurolysis) is the destruction of the signal carrying parts of a nerve. It is a small subset of treatments under the broad umbrella of cryotherapy. Until now, traditional cryotherapy treatments were invasive and used large complicated machines.

The iovera° system has revolutionized the delivery of cryoanalgesia.  With the iovera° system, doctors are able to deliver precise, controlled doses of cold temperature only to the targeted nerve through a handheld device.  This needle-based procedure is safe and does not damage or destroy the surrounding tissue.

The iovera° treatment blocks targeted sensory nerves from sending pain signals. A small probe (also referred to as Smart Tip) is inserted into the treatment region and a treatment cycle is performed. A precise cold zone is formed under the skin—cold enough to temporarily stop the nerve from signaling without damaging surrounding tissue. This is repeated until the nerve is blocked, providing pain relief until the nerve regenerates.

The iovera° treatment is used to treat specific nerves so the pain relief is focused only on the part of the body that is being treated. One treatment with the iovera° system can last 90 days.1

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 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

Important Safety InformationThe iovera° system should not be used in people with the following conditions:

  • Blood that thickens when patient is exposed to cold (cryoglobulinemia), blood appearing in the urine when patient is exposed to the cold (paroxysmal cold hemoglobinuria), skin rash that appears when patient is exposed to the cold (cold urticaria), narrowing of the blood vessels in the hands and feet when patient is exposed to the cold (Raynaud’s disease), and open and/or infected wounds at or near the treatment site

Patients being treated with the iovera° system (a needle-based therapy) may experience certain reactions, including, but not limited to:

  • Bruising, swelling, inflammation and/or redness, local pain and/or tenderness, and altered feeling at the site of application

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

  • In the area(s) where you were treated: damage to the skin from being exposed to cold or heat, darkening or lightening of the skin, and dimples in the skin
  • Outside the area(s) where you were treated: muscles may not work or move normally