GOVERNMENT AFFAIRS

EFFECTIVE SEPTEMBER 1, 2021 PACIRA BIOSCIENCES, INC. - iovera° ADDED TO ECAT

Department of Defense (DOD) and other federal agencies can now order iovera° through the ECAT online ordering system

iovera° is a percutaneous treatment using proven cold therapy (cryoanalgesia) designed to relieve pain associated with chronic osteoarthritis

  • Immediate, safe, and effective1,2
  • Non-systemic3
  • Long-lasting nerve block1
  • Cleared by the US Food and Drug Administration (FDA)

iovera° is appropriate for surgical (i.e, pre-TKA) and non-surgical chronic OA patients including:

  • Patients who chronically cycle through nonsteroidal anti-inflammatory drugs, injections, and opioids
  • Patients who hesitate to have surgery
  • Patients with whom you need to first address risk factors before they are ready for surgery

The following iovera° system components from Pacira BioSciences, Inc. are available via:
ECAT contract # SPE2DE-21-D-7004:

MPN Product Description
IST0221 iovera° System Handpiece and Docking Station
STT0309-5 iovera° Smart Tip 309, 5-pack (3x8.5-mm needles per Smart Tip)
STT0801-5 iovera° Smart Tip 190, 5-pack (1x90-mm needle per Smart Tip)
STT0811-5 iovera° Smart Tip 190 with Nerve Stim, 5-pack (1x90-mm needle per Smart Tip)
CRX0111-10 iovera° Cartridges, 10-pack
CRX0111-20 iovera° Cartridges, 20-pack
ITR0190-10 iovera° Treatment 190, 10-pack (10 Smart Tip 190’s & 20 Cartridges)
ITR0309-10 iovera° Treatment 309, 10-pack (10 Smart Tip 309’s & 30 Cartridges)

To speak with Sales or Technical Support teams:

Please fill out the form to submit a quote request. We will forward your request to Sales.

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Please fill out the form to submit a quote request. We will forward your request to Technical Support.

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TKA = total knee arthroplasty

REFERENCES

  1. Radnovich R, et al. Osteoarthritis Cartilage. 2017;25(8):1247-1256.
  2. Dasa V, et al. Knee. 2016;23(3):523-528.
  3. Ilfeld BM, et al. Expert Med Devices. 2016;13(8):713-725.

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 Information

ContraindicationsThe 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 ComplicationsAs 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