Overview

iovera° Is a Handheld Device That Provides Target Cryoanalgesia

The iovera° system is a novel, FDA-cleared drug-free treatment that alleviates pain through a mechanism known as cryoneurolysis, which applies intensely focused cold therapy to a specific nerve to interrupt its ability to transmit a pain signal. The iovera° system can be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. Results can be felt immediately after iovera° treatment with pain relief that can last up to three months, or in some cases longer, as the nerve regenerates over time.1 It is also indicated for the relief of pain and symptoms associated with knee osteoarthritis (OA) for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue.1

iovera° is a handheld device that applies freezing temperatures to targeted nerve sites. The iovera° handheld device delivers a controlled amount of liquid nitrous oxide to closed-end probes, which are then applied to specific target nerves. As this highly pressurized liquid travels from the handpiece to the probe, it undergoes a phase change and becomes very cold by drawing in heat energy from the surrounding tissue, forming an ice ball at the targeted nerve. The gaseous nitrous oxide returns to the handpiece to be expelled, leaving nothing behind in the body.1

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 stimulation.1

Explore iovera° resources to learn more

iovera° Gen 1 User Guide iovera° Gen 2 User Guide User Guide Addendum, Smart Tip 309 User Guide Addendum, Smart Tip 190 With Nerve Stim Enabled User Guide Addendum, Smart Tip 190 iovera° Dossier iovera° Gen 2 Reference Guide iovera° Gen 2
Troubleshooting Guide FAQ

Reference

  1. iovera°® System User Guide. San Diego, CA: Pacira Pharmaceuticals, Inc.; 2021.

Orthopedic Surgery

Explore information about iovera° for use in orthopedic knee surgery: total knee arthroplasty (TKA).

  • Total Knee Arthroplasty

    Find information related to use of the iovera° system for total knee arthroplasty (TKA).

    View materials right-arrow

Clinical Applications

Explore information about iovera° for use across a variety of surgical procedures: mastectomy, rib fractures and sternal fracture pain, knee osteoarthritis (OA), occipital neuralgia and phantom limb pain.

  • Breast Surgery (Mastectomy)

    Find information related to use of the iovera° system for mastectomy.

    View materials right-arrow

  • Rib Fractures and Sternal Fracture Pain

    Find information related to use of the iovera° system for rib fractures and sternal fracture pain.

    View materials right-arrow

  • Knee Osteoarthritis

    Find information related to use of the iovera° system for knee osteoarthritis (OA).

    View materials right-arrow

  • Occipital Neuralgia

    Find information related to use of the iovera° system for occipital neuralgia.

    View materials right-arrow

  • Phantom Limb Pain

    Find information related to use of the iovera° system for phantom limb pain or pain after limb amputation.

    View materials right-arrow

  • Pain Associated with Spasticity

    Find information related to use of the iovera° system for pain associated with spasticity.

    View materials right-arrow

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

Contraindication

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