COOLIEF* Cooled RF is the only currently known thermal radiofrequency system using water-cooled technology to deactivate pain-causing sensory nerves. Safely delivering more RF energy through water-cooled electrodes creates large-volume, spherically-shaped lesions that distally-project 45% beyond the probe’s tip to enable angle independence of the probe.
Clinically proven to provide up to 24 months of pain relief, improved physical functionality and reduced drug utilization,1,5 COOLIEF* is reshaping thermal radiofrequency.
The COOLIEF* Cooled Radiofrequency System – How it Works
A radiofrequency generator transmits a small current of RF energy through an insulated electrode placed within tissue. Ionic heating, produced by the friction of charged molecules, thermally deactivates the nerves responsible for sending pain signals to the brain. Delivering RF energy through water-cooled electrodes enables more RF energy to be safely delivered to target nerves creating spherically-shaped lesions:
- 5x Larger Volume than standard RF lesions
- Distally Projects 45% or greater beyond the probe tip
- Enables Angle Independence of the Probe
No longer limited to parallel placement, physicians can use the best approach angle to reach and treat nerves located within complex nerve courses.
Standard RF Lesion
With standard RF, lesion size and shape are limited by the heat generated in tissue adjacent to the electrode.
Ionic heat is concentrated at the probe and tissue interface, forming elliptically-shaped lesions immediately adjacent to the active tip.
Cooled RF Lesion
With cooled RF, the moving fluid acts as a heat sink, removing heat away from where tip and tissue interface.
Ionic heat is distributed further from the probe’s active tip, creating large volume, spherically-shaped lesions
COOLIEF* Cooled RF Pain Management Radiofrequency Probe
- Probe includes a 4-foot connecting cable and tubing extension to reach out of the sterile field. These are connected to the generator and peristaltic pump unit for RF energy delivery and internal cooling.
- A thermocouple in the probe measures cooled electrode temperature throughout the procedure.
- A radiopaque marker is located at the proximal end of the active tip. This marker defines the lesion location under fluoroscopy, confirming position and enhancing visualization.
COOLIEF* Cooled RF Pain Management Introducer
The sterile, single use introducer provides a path for the probe to the nervous tissue.
COOLIEF* Cooled RF Pain Management Tube Kit
The sterile, single use tube kit is used for closed-loop circulation of sterile water through the probe. It includes a burette to hold water, connected to tubing that is inserted in the pump unit.
COOLIEF* Cooled RF Pain Management Radiofrequency Generator
The Pain Management Generator PMG-115-TD and PMG-230 (V. 2 or higher) are the only RF generators compatible with COOLIEF* Cooled RF Pain Management Systems
COOLIEF* SINERGY* Sacroiliac Cooled Radiofrequency Pain Management System
An innovative RF treatment for chronic sacroiliac joint pain
The fundamental challenge of treating SIJ pain is capturing the afferent lateral branches coursing between the painful SI region and the posterior sacral foramina. The COOLIEF* SINERGY* Sacroiliac Cooled RF Pain Management System enables placement of large volume lesions, which compensate for the known variability of nerve location and running course of the lateral branches of the posterior rami.
COOLIEF* TRANSDISCAL* Disc Biacuplasty Cooled Radiofrequency Pain Management System
Bipolar, Cooled RF for intervertebral disc biacuplasty – the next generation of treatment for discogenic pain
The COOLIEF* TRANSDISCAL* Disc Biacuplasty Cooled RF Pain Management System uses the COOLIEF* Cooled RF system with a bipolar approach to deactivate nerves to treat symptomatic discogenic pain. Under fluoroscopy, two introducers are placed bilaterally in the posterolateral disc, and then two COOLIEF* TRANSDISCAL* Cooled RF Probes are inserted. The water-cooled probes deliver RF energy with enough power to heat a larger volume of disc tissue while eliminating overheating of adjacent tissue. The result is a large, reproducible lesion within a significant volume of the posterior of the disc.
COOLIEF* Lumbar Cooled Radiofrequency Pain Management System
Perpendicular placement for one-pass, optimal ablation
The COOLIEF* Lumbar Cooled RF Pain Management System uses the cooled RF platform for lumbar medial branch neurotomy. The COOLIEF* Cooled RF Pain Management System enables placement of a large-volume lesion encompassing the medial branch nerve in one pass, eliminating the need for multiple passes. Many patients may fail standard RF treatments, or have a challenging anatomy. The COOLIEF* Cooled RF Pain Management System enables perpendicular placement allowing “gun-barrel” access to target the nerve, compared to standard RF, in which parallel placement to nerve or multiple-pass lesioning is required to achieve optimal ablation.
COOLIEF* Thoracic Cooled Radiofrequency Pain Management System
Cooled RF technology overcomes the challenge
A major challenge in treating chronic, thoracic facet pain comes from the variable course of the medial branch nerve, particularly in the mid-thoracic levels. The COOLIEF* Thoracic Cooled RF Pain Management System overcomes the challenge of the variable nerve course by enabling placement of a large-volume, reproducible lesion, of the size and position that can account for the medial branch variability.
COOLIEF* Cervical Cooled Radiofrequency System
An innovative option for helping resolve cervical facet joint pain
Cervical pain is the third most common pain in the spine with more than 44 million patients afflicted annually. More than 200,000 turn to cervical injections for pain relief; however, cervical pain is often difficult to treat through diagnostic and therapeutic nerve blocks due to nerve course variability and the difficult anatomy of the spine.
The COOLIEF* Cervical Cooled RF System is designed to address the unique anatomy of the cervical joints by employing water-cooled technology anatomically tailored to offer relief in the cervical region. By delivering large volume lesions where anatomy and nerve path are variable, the lesion conforms around ridges and within crevices on irregularly shaped surfaces, enhancing the ability to capture the nerve.
Instructions for Use:
- COOLIEF Cooled Radiofrequency (RF) Kit
- COOLIEF Multi-Cooled Radiofrequency Module
- COOLIEF RF Nitinol Probe and RF Generator Connector Cable
- COOLIEF RF Peristaltic Pump Unit
- COOLIEF RF Probe and RF Generator Connector Cable
- COOLIEF SINERGY Cooled Radiofrequency (RF) Kit
- COOLIEF TRANSDISCAL Cooled Radiofrequency (RF) Y-Connector Cable
- COOLIEF TRANSDISCAL Cooled Radiofrequency (RF) Kit
2 Osteoarthritis Fact Sheet [Internet]. CDC.gov. Centers for Disease Control and Prevention; 2017 [cited 2017Apr12]. Available from: https://www.cdc.gov/arthritis/basics/osteoarthritis.htm
3 AAOS – American Academy of Orthopedic Surgeons. Opioid Use, Misuse, and Abuse in Orthopaedic Practice. Information Statement 1045. http://www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/advistmt/1045%20Opioid%20Use,%20Misuse,%20and%20Abuse%20in%20Practice.pdfPublished October 2015.
4 American Society of Interventional Pain Physicians. Fact Sheet
5 Low Back Pain Fact Sheet. National Institute of Neurological Disorders and Stroke (NIH Publication), 2003.
† When compared to a Stryker 20ga standard RF lesion based upon testing conducted by Avanos, Inc. and compared to Stryker’s published information.
†† A COOLIEF* Cooled RF Probe with a 4mm active tip provides a lesion with an average distal projection of 45.53%. Data on File.
††† Gupta, A. Radiofrequency Ablation Techniques for Chronic Sacroiliac Joint Pain. Pain Medicine News, 2010.
Patel, et al. A Randomized, Placebo-Controlled Study to Assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Medicine. 2012.
Franco, et al. Innervation of the Anterior Capsule of the Human Knee. Reg. Anesthesia and Pain Medicine, 2015.