Non-medicated nerve block technology At Pacira BioSciences, Inc., we are constantly driving innovation to provide better ways to safely and effectively manage pain. iovera°:

  • Delivers cryoanalgesia directly to the site of pain through an innovative, patented handheld design1,2
  • Provides immediate and long-lasting non-opioid relief for postsurgical TKA pain and chronic OA knee pain for up to 90 days1
  • Does not cause permanent damage to surrounding structures2

Enhanced experience and device upgrades We believe in the efficacy and safety profile of iovera° and are committed to continually enhancing the device to improve the user experience and patient outcomes. We recently put these upgrades to the test with health care providers like you.

  • LCD screen indicates cycle stages, Cartridge use, battery power, and more
  • Increased capacity to complete 14 cycles per Cartridge
  • Ergonomic enhancements include balanced weight distribution, making it easier to hold with one hand

Generation 2 device launching in 2021.

TKA=total knee arthroplasty; OA=osteoarthritis.

 

Dr Sean McMillan and PA Danielle Thorn speak about the updated device.

Take their word for it!

Hear clinical experts demonstrate and discuss proven outcomes with iovera°.
“This technology has allowed us to change our entire pain management protocol for TKAs; reducing the number of opioids needed postsurgery and enhancing our physical therapy protocols are just 2 of the resulting benefits.”

—Vinod Dasa, MD, New Orleans, Louisiana

See how your peers have benefited from the proven technology of iovera°.

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The PITT is the place for advancing health care provider education

Innovation has a new home address. The Pacira Innovation and Training Center (PITT) in Tampa provides an unparalleled training environment for health care providers working to reduce or eliminate patient exposure to opioids, with educational sessions including the latest in live model nerve scanning and identification using ultrasound and peripheral nerve stimulation.

How can iovera° work for you?

Discover how iovera° can differentiate your practice. Access templates to write press releases, add information about iovera° to your website, answer FAQs from patients, and more.

Have a question? We let the experts answer.

How does iovera° work? iovera° temporarily freezes nerves in the pain-signaling pathway, providing patients with pain relief for up to 90 days.1,3– Sean McMillan, DO, Burlington County, New Jersey

Is iovera° the same as conventional radiofrequency (RF) and cryoablation? No, iovera° causes second-degree Wallerian degeneration, which means that nerves regain function over time without fear of irreversible nerve destruction or painful neuromas.2,4,5– Sean McMillan, DO, Burlington County, New Jersey

What are the benefits of iovera° compared with traditional pain management protocols? iovera° provides sustained relief of OA and TKA pain, decreasing the need for chronic adjuvant medications such as opioids. While traditional pain management options serve a purpose, many patients are happy to avoid the side effects associated with narcotic use to control pain.1,2,6– Sean McMillan, DO, Burlington County, New Jersey

What clinical study data do you have for presurgical use of iovera° in TKA? Dasa et al. a single site retrospective study of 100 patients where 50 patients in the treatment group received iovera˚ and 50 in the control group did not, demonstrated that patients treated with iovera˚ before TKA had a shorter length of stay and decreased opioids prescribed compared to a standard of care treatment group. This is significant because it will help us minimize the length of patient stays for TKA and, in some instances, allow for successful outpatient arthroplasty.2– Sean McMillan, DO, Burlington County, New Jersey

What are the study data for iovera°? We continue to be fueled by studies that demonstrate the value of iovera°, as well as countless real-world success stories that range from decreased or eliminated opioid consumption and a faster road to rehabilitative therapy, to discharge on the same day of surgery.2– Nirav Amin, MD, Pomona, California

Does iovera° permanently destroy nerves? No, the effect of iovera° does not cause permanent nerve damage to the exterior nerve structure. It causes second-degree Wallerian degeneration, which means that nerves regain function over a period of time. This allows for successful pain relief with minimal-to-no risk of neuritis.2,4,5,8– Sean McMillan, DO, Burlington County, New Jersey

How do results with iovera° compare with RF and nerve block? Medicated blocks are safe with proper dosing and administration, but have a short duration of a few hours to up to 5 days for single-shot blocks. RF is long-lasting, but it is an ablative procedure that puts the patient at risk for long-term neuritis and/or damage to adjacent tissue. It is also the most expensive of these 3 options. iovera° treatment provides the advantages of RFA and medicated nerve blocks but with fewer risks: it is very safe with no risk to surrounding tissue or blood vessels.1,5,7,8– Pieter Vreede, MD, Noblesville, Indiana

I’m interested in iovera°. Who can I contact to learn more? On www.iovera.com, click on the Contact Us link for more information. Pacira BioSciences, Inc., has developed a large network of experienced providers who can give you more information, and the PITT Training Center, located in Tampa, provides opportunities for continuing education and hands-on training with the iovera° device. – Sean McMillan, DO, Burlington County, New Jersey

What should my patients expect from iovera°? With iovera°, patients can expect up to 3 months of relief from OA pain.1– Scott Sigman, MD, Lowell, Massachusetts

Is iovera° treatment painful? Treatment with iovera° is minimally painful. After the area is numbed, treatment is virtually painless. – Scott Sigman, MD, Lowell, Massachusetts

Can the use of iovera° help decrease my patients’ need for opioids post-TKA? Yes, clinical studies have shown that treatment with iovera° can significantly decrease the need for opioids post-TKA.2– Scott Sigman, MD, Lowell, Massachusetts

What sort of pain relief can patients expect with iovera°? Most patients treated with iovera° report significant relief of OA knee pain. In fact, iovera° allows many of these patients to delay TKA. For patients who do undergo surgery, iovera° has been shown to provide significant pain relief and a decreased need for opioids.2– Scott Sigman, MD, Lowell, Massachusetts

How will iovera° impact my patients’ postoperative recovery? In my practice, I find that most patients treated with iovera° can stop pain medication within 2 weeks. I have also seen improved recovery timelines, and less pain during the rehabilitation process.2– Scott Sigman, MD, Lowell, Massachusetts

Does treatment with iovera° need to be performed by the surgeon or anesthesiologist, or can other members of staff administer the treatment? After proper training, health care staff beyond the surgeon or anesthesiologist can administer treatment with iovera°. – Pieter Vreede, MD, Noblesville, Indiana

Can iovera° be used for deeper nerves or structures? Yes, it can. In principle, any sensory peripheral nerve that can be blocked with local anesthetic can potentially be treated with iovera°. For example, it can be used for deep genicular blocks for chronic OA knee pain. Always be aware of adjacent nerves that could be within the cryogenic freeze zone when considering the use of iovera° for a specific nerve block. – Pieter Vreede, MD, Noblesville, Indiana

How is iovera° reimbursed? Pacira BioSciences, Inc., has a dedicated reimbursement hotline to help determine the reimbursement policies in your region. As with most procedures, iovera° treatment reimbursement may vary; however, using specific provided codes can improve payment and reimbursement for the services rendered. – Sean McMillan, DO, Burlington County, New Jersey

Is the capital investment for implementing iovera° in my practice excessive? It is not. Pacira BioSciences, Inc., has a mission to provide high-quality, low-cost, opioid-sparing alternatives for physicians and patients. The costs associated with the iovera° treatment system are not prohibitive, and individualized capital investment conversations can help ensure that all patients receive the highest quality care. – Sean McMillan, DO, Burlington County, New Jersey

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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. Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis for treatment of acute pain: could cryoanalgesia replace continuous peripheral nerve blocks? Br J Anaesth. 2017;119(4):703-706. 4. Evans PJ. Cryoanalgesia: the application of low temperatures to nerves to produce anaesthesia or analgesia. Anaesthesia. 1981;36(11):1003-1013. 5. Zhou L, Craig J, Parekh N. Current concepts of neurolysis and clinical applications. J Analgesics. 2014(2):16-22. 6. Data on File. 2914. Parsippany, NJ: Pacira BioSciences, Inc.; June 2017. 7. Davis T, Loudermilk E, DePalma M, et al. Prospective, multicenter, randomized, crossover clinical trial comparing the safety and effectiveness of cooled radiofrequency ablation with corticosteroid injection in the management of knee pain from osteoarthritis. Reg Anesth Pain Med. 2018;43:84-91. 8. lfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016;13(8):713-723.

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