Treatment

Is the iovera° treatment for me?If your knee pain is chronic, due to osteoarthritis, it can be alleviated by cryoanalgesia with the iovera° treatment. The iovera° system has also been shown to help in reducing opioid consumption in patients after surgery. Postsurgical pain is considered to be acute pain.

The iovera° treatment is a focused therapy; therefore, there are no side effects to the entire body. Nothing is injected into the treatment area by the iovera° system. Therefore, very few, if any, localized side effects due to the iovera° treatment have been observed and side effects are mild.1 Please click here to see the Indication and Important Safety Information. You should consult with your physician to determine if cryoanalgesia with the iovera° system will benefit you.

Decreased Knee Pain

Patients who received iovera° treatment continued to experience pain relief at 90 days1

Less Stiffness

Patients treated with the iovera° system experienced less stiffness 30 days after treatment1

Improved Physical Function

Patients in the iovera° treatment group had improved physical function at 90 days1

Fewer Opioid Prescriptions

Patients who received iovera° treatment requested 45% fewer opioid prescriptions at 12 weeks after knee replacement surgery2

Reduction in Knee Pain

2 weeks after surgery, patients treated with iovera° experienced less pain2

Faster Discharge

More patients treated with iovera° were discharged within 2 days of surgery2

What kind of results can I expect?Results from the iovera° treatment can be felt immediately after treatment. When the treatment is applied to a specific nerve, it will interrupt that nerve’s ability to send a pain signal, providing an immediate reduction in pain.

How long do results last?The treatment effect is immediate and lasts until the nerve has fully regenerated. Treatment results may vary by individual and the location of treatment. In general, nerves regenerate at a rate of approximately 1 to 2 mm per day. In a randomized, multicenter study focused on knee osteoarthritis, 77% of iovera° patients experienced a reduction in pain for up to 90 days.1

Could this replace the need for knee surgery or other therapies?The iovera° treatment has been performed prior to knee surgery to assist in prehabilitation exercises, as well as closer to the time of surgery to help reduce pain during surgery and pain in the critical weeks3 following surgery. The effect is temporary, helping you manage your pain. It does not change the underlying condition for which your physician has recommended surgery or other therapies.

Preparing for iovera° treatment

Prior to treatment, your physician will discuss any daily medications you take, such as blood thinners or pain medications, as well as your health history and any health conditions you may have. Please discuss your treatment history with your physician before your scheduled iovera° treatment appointment:

  • Previous surgery, treatment, trauma, or a medical diagnosis in the area to be treated
  • A history of keloid formation, reactions to lidocaine or sensitivity to pain or cold
  • Open sores or wounds in the are to be treated
  • Regular use of anti-coagulants (eg, Coumadin, fish oil), aspirin or NSAIDs (eg, ibuprofen)

What should I be doing?There are no special pretreatment instructions for you to follow:

  • Wear comfortable clothing that allows access to the treatment area (ie, for knee)

The day of iovera° treatmentYour physician or his office staff will:

  • Assess your pain
  • Clean and mark the treatment area
  • Numb the area with an anesthetic injection or cold spray (you may feel a slight pinch)

What should I expect during the iovera° treatment?

  • Treatment takes around 15 to 30 minutes per area treated
  • You may feel pressure or tugging when the iovera° Smart Tip is inserted
  • During the treatment, it is normal to experience cold, warm, or tingling sensations as well as some level of discomfort, often described as pressure
    • Treatment should not be painful; if you feel pain, tell your provider right away

After iovera° treatment

Immediately following treatment:

  • Apply pressure (10–15 minutes) to the treatment area to reduce swelling or bruising
  • Apply ice after applying pressure

Following the proper after-care instructions is key to minimize the occurrence and/or duration of expected side effects

When at home follow these simple instructions:

  • Keep the treatment area clean and dry during healing
  • Use ice or over-the-counter pain medication to relieve soreness
  • Your physician can offer you guidance on medication
  • Unless specifically directed, avoid blood-thinning drugs (eg, ibuprofen, aspirin) for 48 hours
  • Avoid exercise or exertion for 2 to 5 days
  • Your physician will advise you on returning to normal activities and safe levels of exertion or stress
  • Following the proper after-care instructions is key to minimize the occurrence and/or duration of expected side effects

The results of iovera° treatment are immediate. Listed below are normal and temporary responses to the treatment that some patients may experience:

  • Treatment area may feel tender and/or warm
  • Some numbness or mild tingling may be present in the treatment area
  • Some swelling and/or bruising may occur

Other Frequently Asked Questions

Does the treatment hurt?A local anesthetic will be administered to the area before treatment. While the treatment should not be painful, it is normal to experience pressure, a sensation of cold, warmth, tingling and/or tapping during treatment. This altered sensation during treatment is an indication that the treatment is working.

Are there any side effects?Common side effects include local pain, tenderness, swelling, bruising, and tingling or numbness. Typically, these reactions resolve with no physician intervention. For a list of possible side effects, please click here.

How soon can I return to activity?Post-treatment activity instructions are at the discretion of your physician. You may return to non-strenuous activity immediately after receiving the iovera° treatment. However, your physician may have additional instructions prior to any planned surgery. Consult your physician regarding appropriate levels of activity.

REFERENCES

  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.
  2. Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016;23(3):523-528.
  3. Evans PJ, Lloyd JW, Green CJ. Cryoanalgesia: the response to alterations in freeze cycle and temperature. Br J Anaesth. 1981;53(11):1121-1127.

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
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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