iovera° indication and important safety information

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.


Important Safety Information

The 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: the area(s) where you were treated: muscles may not work or move normally

  • 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