FDA OKs Avanos Medical’s RF System for Neurological Lesions

The U.S. Food and Drug Administration (FDA) has cleared for marketing Avano Medical’s new, 80-Watt COOLIEF* Radiofrequency (RF) system for neurological lesion procedures. This system, comprised of a newly designed RF generator, peristaltic pump, and therapy cables, enables physicians to perform a full spectrum of procedures including Cooled, Standard, Pulsed, TransDiscal, and dual Bipolar RF.
 
Cooled RF is a non-opioid, minimally invasive outpatient pain management procedure that uses cooled radiofrequency energy to safely treat chronic pain by targeting the sensory nerves causing pain. Approximately 100 million U.S. adults—more than the number affected by heart disease, diabetes, and cancer combined—suffer from chronic pain conditions. Several studies have shown that the use of opioids to treat chronic pain, may actually worsen pain and functionality.
 
“Avanos’ new Cooled RF system is intuitive and easy to use,” stated Dr. Maged Guirguis, system chair of pain medicine at Ochsner Health. “The Cooled RF technology has not only helped our patients achieve significant relief from osteoarthritis pain, but it has also improved their function, thus providing a better quality of life.”
 
This new system, which provides 60 percent more power than the legacy system, features an intuitive touchscreen interface, and independent channel control that enables physicians to start, stop and adjust on 4 probes individually, which enhances ease of use and efficiency.
 
“For over a decade, Avanos has been committed to driving innovation and investing in clinical evidence in RF technology,” stated Joe Woody, Avanos’ CEO. “The addition of our new, advanced COOLIEF* RF generator demonstrates this continued commitment to introduce innovation to the marketplace as the Cooled RF authority and to provide relevant solutions that help patients effectively manage pain without the risk of addiction, so they can get back to things that matter. We’re excited to debut the new system at the upcoming American Society of Interventional Pain Physicians annual meeting.”