Radio-frequency ablation system generator

Intended purpose

The COOLIEF Radiofrequency Generator (CRG) is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The device is to be used in conjunction with separately approved probes. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.