ALPHARETTA, Ga., Sept. 3, 2020 /PRNewswire/ -- Avanos
Medical, Inc. (NYSE: AVNS) today announced the publication of a
large, randomized, multicentered clinical trial comparing the
safety and efficacy of COOLIEF* Cooled Radiofrequency ablation to
hyaluronic acid (HA) injection for the management of chronic knee
pain caused by osteoarthritis. The results from the clinical trial
were published in the Journal of Bone & Joint Surgery,
the official journal of the American Orthopedic Association.
Knee osteoarthritis is a painful and sometimes debilitating
condition affecting more than 9 million people in the United States alone. Existing treatments
consist of short-lasting and often repetitive nonsurgical options,
followed by surgical intervention for those who are appropriate
candidates. COOLIEF* Cooled RF is an FDA cleared minimally invasive
procedure that has shown extended clinical durability in the
management of knee OA pain.
This clinical trial enrolled 177 subjects that met inclusion
criteria who were subsequently randomized to receive either cooled
radiofrequency ablation (CRFA) or a single hyaluronic acid (HA)
injection. Subjects were evaluated for pain (Numerical Rating Scale
= NRS), function (Western Ontario
& McMaster University
Osteoarthritis Index = WOMAC), quality of life (Global Perceived
Effect = GPE) and safety at 1, 3 and 6 months.
At the 6-month timepoint, 71.1% of subjects receiving CRFA
reported ≥ 50% pain relief compared to 37.8% of subjects receiving
HA. Those receiving CRFA had a 48.2% improvement in WOMAC score at
6 months, compared to 22.6% of subjects treated with HA.
Additionally, 72.4% of subjects in the CRFA group reported
improvements in GPE compared to 40.2% in the HA group.
"I am very encouraged by the results from this clinical trial,"
said Dr. Lynn Kohan, associate
professor at the University of Virginia
Medical School, an investigator in the clinical trial. "The
non-operative knee OA patient used to be one of my hardest patients
to treat because there simply weren't safe and effective treatments
with good clinical durability. Now, when I see these patients, I am
excited to share this treatment option with them."
While the manuscript published today in The Journal of Bone
& Joint Surgery represents the 6-month timepoint, the
clinical trial was designed to capture longer follow-up with
subjects receiving CRFA. The 12-month, 18-month and 24-month
timepoints will be reported in future publications.
"We are excited to announce the publication of this trial," said
Tom Kupec, vice president and
general manager, interventional pain at Avanos, "and I am most
pleased about the fact that these results show tremendous
consistency in response when compared to previously published trial
data on COOLIEF* Cooled RF. We continue to invest in high-quality
clinical research and are pleased that these results were accepted
for publication in such a prestigious journal."
About COOLIEF* Cooled RF: COOLIEF* Cooled RF uses
water-cooled technology that enables more RF energy to safely
deactivate pain-transmitting sensory nerves. This creates a larger,
spherical lesion that distally projects 45% or greater beyond the
probe's tip, allowing physicians to approach the target nerve from
any angle. These features increase the likelihood of successful
ablation and improve patient outcomes. COOLIEF* Cooled RF has been
shown to provide up to 24 months of pain relief, improved physical
functionality, and reduced drug utilization.
About Avanos Medical:
Avanos Medical (NYSE: AVNS) is a
medical technology company focused on delivering clinically
superior breakthrough medical device solutions to improve patients'
quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to
addressing some of today's most important healthcare needs, such as
reducing the use of opioids while helping patients move from
surgery to recovery. Avanos develops, manufactures and markets its
recognized brands in more than 90 countries. For more information,
visit www.avanos.com and follow Avanos Medical on Twitter
(@AvanosMedical), LinkedIn and Facebook.
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SOURCE Avanos Medical, Inc.