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LESS PAIN, FEWER OPIOIDS

2x

Significant pain reduction to help
patients recover

2x the improvement in KOOS symptom score
(vs control group) at both week 6 and week 12 post-TKA1,2

The iovera° group demonstrated significant reductions
in PROMIS® pain intensity and pain interference at 2- and
6-week follow-up, respectively (P<0.0001)1

45%

Reduced reliance on opioids*

45% reduction in opioid consumption during the 12 weeks following surgery1

In this study, the most common side effect was bruising at the injection site1

Study Design: Retrospective chart review (N=100). Treatment group included first 50 patients treated with cryoneurolysis, plus multimodal treatment following its adoption in the practice for TKA. Control group was 50 patients treated with multimodal approach alone. Treatments were administered 5 days prior to the scheduled TKA.

Percutaneous freezing of sensory nerves
prior to total knee arthroplasty

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FASTER RECOVERY OF CLINICALLY MEANINGFUL ROM3

At 6 weeks post-tka

≥120°
Flexion attained
by 20% of patients

108°
Average flexion

knee flexion
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improved
recovery of rom3

at Weeks 2, 6, and 12 post-TKA for early and sustained knee movement

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Demonstrated
shorter LOS3

(0.8 vs 2.5 days; P<0.0001)

Study Design: Retrospective chart review (N=323) of patients treated with standard recovery practice (n=129) and those with a rapid recovery protocol that included cryoneurolysis (n=194).

Rapid vs standard recovery protocol is associated with improved recovery of range of motion 12 weeks after total knee arthroplasty

REDUCED OPIOID USE AND IMPROVED KOOS SCORES4

34%

  • 34% fewer opioids were required 6 weeks after discharge in a per-protocol analysis (mean, 4.2 mg vs 5.9 mg; P=0.0186)
    • Lower opioid consumption at Day 3 and 6 weeks through
      12 weeks after discharge
    • More opioid-free patients at 6 weeks after discharge
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Study Design: Single-site (N=124) prospective study of patients randomized 1:1 between a treatment group (iovera° 3 to 7 days prior to TKA) and a control group (standard of care TKA).

Cryoneurolysis before total knee arthroplasty in patients with
severe osteoarthritis for reduction of postoperative pain and
opioid use in a single-center randomized controlled trial

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FEWER OPIOIDS, BETTER RANGE OF MOTION, REDUCED LENGTH OF STAY5

COMPARED WITH THE CONTROL GROUP, THE iovera° GROUP DEMONSTRATED:

51%

51% lower adjusted mean daily opioid consumption

68%

68% reduction in total adjusted mean opioid consumption

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IMPROVED
KNEE
FLEXION

Significant knee flexion and extension at discharge5

  • 98% had flexion ≥90° vs 80% in the control group
  • 97% had extension ≤5% vs 79% in the control group

SHORTENED
HOSPITAL
LOS

Significant reduction in overall hospital LOS5

  • Less than 1 of 5 (17%) of patients had an overall LOS ≥2 days vs nearly all (99%) of patients in the control group (P<0.0001)

Study Design: A single-site retrospective chart review of patients (N=267) undergoing an inpatient primary TKA with 169 subjects treated with iovera° (treatment group) and 98 subjects who did not receive cryoneurolysis (control group).

A multimodal pain management protocol including preoperative
cryoneurolysis for total knee arthroplasty to reduce pain,
opioid consumption, and length of stay

AAOS=American Academy of Orthopaedic Surgeons; AUC=area under the curve; KOOS JR=Knee Injury and Osteoarthritis Outcome Score Joint Replacement; LOS=length of stay; PROMIS=Patient-Reported Outcomes Measurement Survey; ROM=range of motion; TKA=total knee arthroplasty.

References: 1. Dasa V et al. Knee. 2016;23(3):523-528. 2. Data on file. Pacira BioSciences, Inc.; 2021. 3. Plessl D et al. J Am Acad Orthop Surg 2020;28: e962-e968 4. Mihalko WM et al. J Arthroplasty. 2021;36(5):1590-1598. 5. Urban JA et al. Arthroplast Today. 2021;10:87-92.

See iovera° in action

Learn how to
administer 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
More +

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