Up to 56% reduction in WOMAC pain scores from baseline1

reduction chart mobile

The most common side effects were bruising, numbness, redness, tenderness on palpation, and swelling.

Study Design: Randomized, double-blind, sham-controlled, multicenter trial with a 6-month follow-up in patients with knee OA. Patients were randomized 2:1 to cryoneurolysis targeting the infrapatellar branch of the saphenous nerve (ISN) or sham treatment (N=180; 121 in active group, 59 received sham).1

Treatment with iovera° helped patients get moving1*

  • Significant improvements in physical function demonstrated at Day 30 (P=0.001), Day 60 (P=0.04), and Day 90 (P=0.017)
  • Significant reduction in stiffness at Day 90 (P=0.03)

Knee pain
Clinical Practice
Guideline cite
Radnovich as a
“high quality
study”1

AAOS=American Academy of Orthopaedic Surgeons; CPG=clinical practice guidelines; ISN=infrapatellar branch of the saphenous nerve; OA=osteoarthritis; TKA= total knee arthroplasty; WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index.

*iovera° therapy does not treat the underlying cause of the pain; timely remediation is necessary to address the root cause.

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

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Indication

The 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.

When stimulation compatible components are used, the iovera° system can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

Important Safety Information

Contraindications

The 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 Complications

As 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
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Indication

The 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.

Important Safety Information