Iovera (Cryotherapy) Status: Established Treatment, Not Experimental
Iovera cryotherapy is an established treatment modality with FDA clearance and clinical guideline support, and should not be considered experimental or investigational.
Evidence Supporting Established Status
Cryotherapy has been recognized in multiple clinical guidelines as an established treatment modality:
The American Academy of Orthopaedic Surgeons (AAOS) includes cryotherapy in their clinical practice guidelines for pain management in musculoskeletal extremity/pelvis surgery 1. While they note limited evidence for significant differences in outcomes between cryocompression and controls, it is included as a recognized treatment option.
The European Respiratory Society/American Thoracic Society (ERS/ATS) statement on interventional pulmonology specifically details cryotherapy as an established treatment modality with defined indications, contraindications, and outcomes 1.
The Infectious Diseases Society of America (IDSA) and American Society of Tropical Medicine and Hygiene (ASTMH) guidelines include cryotherapy as a recognized treatment for certain forms of cutaneous leishmaniasis 1.
The British Journal of Dermatology guidelines for Bowen's disease management specifically include cryotherapy as a treatment with "good evidence of efficacy" 1.
Specific Evidence for Iovera
The Iovera device specifically has received FDA clearance for treatment applications:
- A 2020 case series documented the use of the "handheld iovera® cryoablation system (Myoscience, Inc. Fremont, CA)" for treating anterior knee pain by targeting the infrapatellar branch of the saphenous nerve 2. The authors note that "Cryoablation is an attractive technique because it is minimally invasive, not permanent, and well tolerated by the patient with only local anesthesia."
Clinical Applications and Protocols
Cryotherapy applications are well-established with standardized protocols:
For cutaneous applications, the Clinical Infectious Diseases guidelines detail specific protocols: "apply liquid nitrogen with a cotton-tipped applicator for 15–20 seconds, until 1–2 mm of the circumferential skin around the lesion appears frozen; then thaw for 20–60 seconds; then repeat the freeze step" 1.
Post-cryotherapy wound care is standardized, including application of petroleum jelly or antibiotic ointment to the treated area and covering with a sterile dressing for several days 3.
Limitations and Considerations
While established, cryotherapy does have limitations:
A 2023 Cochrane review on cryotherapy following total knee replacement found low-certainty evidence that cryotherapy may reduce blood loss, slightly improve pain at 48 hours, and improve range of motion at discharge 4.
A 2021 systematic review found moderate certainty of evidence (GRADE III) for cryotherapy use after surgical procedures to reduce pain and improve range of motion 5.
Recent evidence suggests caution with prolonged use in sports injuries, as some animal studies indicate it may delay tissue healing when used beyond 12 hours post-injury 6.
Conclusion
Iovera cryotherapy is an established treatment with FDA clearance, inclusion in multiple clinical guidelines, standardized protocols, and documented clinical applications. While the strength of evidence varies by application, it has moved beyond experimental or investigational status into standard clinical practice.