What is iovera°?
A HANDHELD DEVICE THAT PROVIDES TARGETED, LONG-LASTING PAIN RELIEF THROUGH
CRYONEUROLYSIS
Cryoneurolysis is the freezing of the signal-carrying parts
of a nerve
The iovera° system creates a “cold zone” that blocks nerve signals and immediately reduces pain—without the use of drugs*:
Targeted cold is applied directly to a peripheral nerve
iovera° uses nitrous oxide and the body’s own fluid to create a PRECISE COLD ZONE UNDER THE SKIN cold enough to immediately prevent the nerve from sending pain signals without causing damage to the surrounding structures
The effect on the nerve is temporary, providing pain relief until the nerve regenerates and function is restored
The iovera° treatment does
not include the injection of opioids
Pain relief can last up to 90 days per treatment1
Cryoneurolysis with iovera° provides targeted pain relief without permanently damaging nerves
1
TREATMENT
Cold zone is created around the targeted nerve, reaching a temperature of -88°C
2
DEGENERATION
Cold zone causes degeneration of axon and myelin sheath, temporarily blocking nerve signals
3
REGENERATION
Following treatment,
the axon regenerates at
about 1 to 2 mm/day2
4
REINNERVATION
The axon and myelin sheath are fully regenerated, and nerve signaling is restored
*iovera° therapy does not treat the underlying cause of the pain; timely remediation is necessary to address the root cause.
References: 1. Radnovich R et al. Osteoarthritis Cartilage. 2017;25(8):1247-1256. 2. Evans PJ et al. Br J Anaesth. 1981;53(11):1121-1127.
See iovera° in action
Who can benefit from
treatment with iovera°?
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
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