Focus of the Report: This report evaluates cooled radiofrequency ablation (CRFA) using the Coolief Cooled Radiofrequency system (Avanos Medical Inc.) for pain associated with knee osteoarthritis (KOA).
Technology Description: CRFA is intended to use less heat than conventional radiofrequency ablation (RFA), with the intent of more effectively stopping the transmission of pain signals and reducing pain by producing larger spherical neuronal lesions in sensory nerves. For the treatment of painful KOA, the genicular nerves are targeted. Coolief is a CRFA device cleared for marketing by the Food and Drug Administration (FDA) as substantively equivalent to predicate CRFA systems.
Controversy: In general, RFA of any type is considered investigational or experimental by representative payers due to lack of establishment of efficacy. The effects of RFA in general are temporary and generally limited to 1 year, as pain signal transmission will return with peripheral nerve regrowth and regeneration. Whether use of a cooler probe leads to better outcomes than RFA or other active treatments is under investigation and not yet established.
Key Questions:
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Is CRFA with the Coolief Cooled Radiofrequency system (Avanos Medical Inc.) effective for treating pain associated with KOA?
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How does CRFA with the Coolief Cooled Radiofrequency system compare with alternative treatments for pain associated with KOA?
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Is treatment with the Coolief Cooled Radiofrequency system safe?
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Have specific patient selection criteria for the Coolief Cooled Radiofrequency system been established?
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