REDUCED PAIN AND OPIOID USE
WITH FASTER ROM RECOVERY
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
FASTER RECOVERY OF CLINICALLY MEANINGFUL ROM3
At 6 weeks post-tka
≥120°
Flexion attained
by 20% of patients
108°
Average flexion
improved
recovery of rom3
at Weeks 2, 6, and 12 post-TKA for early and sustained knee movement
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).
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
- Lower opioid consumption at Day 3 and 6 weeks through
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
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
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).
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
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