Indication for Use Statement

The ioverao 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 ioverao system’s “1×90” 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.

The ioverao system is not indicated for treatment of central nervous system tissue.

Contraindications

The system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; Cold urticaria; Raynaud’s disease; open and/or infected wounds at or near the treatment line.

Side Effects

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

  • Bruising (ecchymosis)
  • Swelling (edema)
  • Inflammation and/or redness (erythema)
  • Pain and/or tenderness
  • Altered sensation (localized dysesthesia)

Typically, these reactions resolve with no physician intervention.

Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the counter analgesics.