Countdown toNOPAIN Act:

56

Days

ASP+6% CMS reimbursement for proven non-opioids used in all outpatient surgical settings is coming January 1, 2025.

ioveraº allows health care providers to control pain by delivering precise, controlled doses of cold temperature to a targeted nerve

The ioveraº technology represents a revolutionary cryotherapy platform

The ioveraº system is a novel, FDA-approved non-opioid treatment that alleviates pain through a mechanism known as cryoanalgesia, which applies intensely focused cold therapy to a specific nerve to interrupt its ability to transmit a pain signal. Results can be felt immediately after ioveraº treatment with pain relief that can last three months, and in some cases longer, as the nerve regenerates over time.1

treatment

I. Treatment

A cold zone is created, lowering the temperature to below -20ºC.

degeneration

II. Degeneration

Cold zone causes degeneration of the axon and myelin sheath, temporarily blocking nerve signals.

regeneration

III. Regeneration

Post treatment, the axon regenerates at the rate of about 1 to 2 mm per day.

reinnervation

IV. Reinnervation

The axon and myelin sheath are fully regenerated and nerve signaling is restored.

The ioveraº system can play an integral role in the management of pain associated with both orthopedic surgery and persistent orthopedic conditions such as osteoarthritis

Proven treatment results with ioveraº

treatment results for chronic pain

degeneration

DECREASED KNEE PAIN

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

degeneration

LESS STIFFNESS

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

degeneration

IMPROVED PHYSICAL FUNCTION

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

Treatment results for acute (surgical) pain

degeneration

FEWER OPIOID PRESCRIPTIONS

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

degeneration

REDUCTION IN KNEE PAIN

2 weeks after surgery, patients treated with ioveraº experienced less pain2

degeneration

FASTER DISCHARGE

More patients treated with ioveraº were discharged within 2 days of surgery2

About ioveraº

The ioveraº system is used to ablate nerve tissue during surgical procedures by applying freezing cold. It can also be used to freeze 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. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 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.

Important Safety Information

The ioveraº 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. Potential complications: 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.

References
  1. Radnovich, R. et al. “Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.” Osteoarthritis and Cartilage (2017) p1-10.

  2. Dasa, V. et al. “Percutaneous freezing of sensory nerves prior to total knee arthroplasty.” The Knee (2016) p523-528.