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According to the CDC (2019), Osteoarthritis (OA) affects over 30 million adults in the U.S. OA is caused by damage or the breakdown of cartilage between joint bones that leads to joint pain, swelling and stiffness.. OA is usually treated with increasing physical activity, physical therapy, weight loss, medications (OTC and prescription), supportive devices, and surgery if other treatment options have not been successful.

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Learn about the causes, symptoms, and treatments of osteoarthritis in this patient friendly video.

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COOLIEF Cooled Radiofrequency technology was develop by Halyard Health (HYH), a medical technology company based in Alpharetta, Georgia. HYH is committed to develop technologies that help with pain elimination, fast recovery and infection prevention.
Clinical trials for effectiveness of COOLIEF were started in 2015. COOLIEF was officially approved by the FDA on April 20, 2017 as the first and only treatment for the relief of moderate to severe chronic knee pain that is caused by OA. The clearance for use of COOLIEF was approved based on results from a HYH sponsored randomized controlled trail that compared COOLIEF to steroid injections over 12 months. Dr. Timothy Davis, founder and medical director of Orthopedic Pain Specialist in Santa Monica, California authored the study. The study found that 74.1% of the COOLIEF group reported reduced pain by at least 50% at six months and maintained in over 65.4% for the full 12 months post intervention.

COOLIEF was posted on Medgadget.com in May 2017. Here is the link -

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Halyard Health, a company out of Alpharetta, Georgia, landed FDA clearance for its COOLIEF Cooled Radiofrequency technology to be used for treatment of moderate to severe chronic knee pain arising from osteoarthritis. It may be particularly beneficial for patients who are poor candidates for knee replacements or that may choose to wait for whatever reason. This is the first radiofrequency (RF) therapy that has been cleared by the FDA for pain relief in osteoarthritic knees. Halyard believes that its system may help many patients avoid drugs and steroid injections, that come with their unique side effects and potential for addiction.

COOLIEF delivers RF energy onto targeted nerves while using cold water to cool the surrounding area. This provides the ability to deactivate nerves while avoiding unwanted damage to nearby tissues.

Here's some info about the study that led to this regulatory green light:

This new clearance is based on results from a 151-patient prospective, randomized multi-center study comparing COOLIEF Cooled RF to intra-articular steroid injections in patients suffering from knee pain due to osteoarthritis. In 74.1 percent of the cooled RF patient group, pain was reduced by at least 50 percent at six months and maintained in over 65.4 percent of those patients for a full 12 months post procedure. At baseline, 67.1 percent of the cooled RF group and 62.7 percent of the steroid injection group reported symptoms of severe arthritis. Results indicate that six months post-procedure, only 5.2 percent of the cooled RF group reported the same severity level versus 37.3 percent of patients treated with steroid injections, as measured by the Oxford Knee Score ¹. In addition, the cooled RF patient group's Oxford Knee Score remained low for 12 months with only 11.5 percent reporting severe symptoms at that point.

Here's a video of the procedure:

Product page: COOLIEF Knee Cooled Radiofrequency...

Via: Halyard Health...

Editors
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COOLIEF Cooled Radiofrequency Cleared to Relieve Pain in Osteoarthritic Knees |

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Halyard Health, a company out of Alpharetta, Georgia, landed FDA clearance for its COOLIEF Cooled Radiofrequency technology to be used for treatment of moderate to severe chronic knee pain arising from osteoarthritis. It may be particularly beneficial for patients who are poor candidates for knee replacements or that may choose to wait for whatever reason.

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"Radiofrequency ablation deactivates the nerves responsible for sending pain signals to the brain. COOLIEF is the only currently known radiofrequency pain management system using water-cooled technology to safely deactivate pain-transmitting sensory nerves, allowing a larger treatment area and greater chance at targeting pain-causing nerves. COOLIEF is clinically proven to provide long-term pain relief, improve physical functionality, and reduce drug utilization" (MyCOOLIEF,  n.d.).

COOLIEF is a new minimally invasive thermal radiofrequency (RF) technology that can help management of OA knee pain. It delivers RF onto targeted nerves (specifically the superior lateral, superior medial, and inferior medial genicular nerve) while also circulating water to cool the surrounding treatment area. By doing this, it targets and deactivates pain-causing nerves without excessive heating to avoid unwanted damage to nearby tissues.

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The Coolief procedure is a minimally invasive treatment to relieve arthritis knee pain using radio energy waves to interrupt pain signals. Coolief is ideal for the management of osteoarthritis-related pain when surgery is not an option due to medical reasons. It has been shown to provide several months of pain relief eliminating the need for daily pain medication.

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The COOLIEF system is easy to set up and doctors must be trained before they can use. It is usually performed as an outpatient procedure under image guidance. Needles and water-cooled electrodes will be inserted into genicular nerves. Following the procedure, some discomfort and pain may be experienced at the needle sites.

Video on how to use COOLIEF

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Cooled Radiofrequency Lesioning of the Genicular Nerves

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Cooled radiofrequency lesioning of the genicular nerves. Tagged with knee pain, non-surgical knee procedure, osteoarthritis, total knee replacement.

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Minimally invasive

Done in outpatient setting, no overnight hospital stays

No incision (besides needle insertion site)

May reduce use of pain medications, narcotics, and steroid injections

Can be option for patients who are not suitable or ready for knee surgery

If effective, pain relief for 6 months to 24 months

Improved mobility

Quick recovery time

Higher patient satisfaction than steroid injections

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New technology with limited studies

Limited specialty-trained COOLIEF doctors

Only approved for knee pain

Not a permanent fix for OA knee pain

May not be covered by insurance

Common side effects – temporary numbness, temporary pain at procedure site

Rare serious side effects – bleeding, infection, nerve damage

Not 100% guaranteed pain reduction

Outpatient setting can pose risk if adverse event happens

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OA affects millions of adults in the United States and the pain caused by OA can affect individuals physically and pyschosocially. Initial treatments for knee pain often include nonsteroidal anti-inflammatory drugs, opioids and steroid injections. Medications usually only provide short-term relief and comes with serious risks like abuse and dependence.
Many patients with OA will try unsuccessfully for years to treat their knee pain before turning to surgery. Furthermore, surgery is not always an option for all patients. Due to BMI, age, co-morbidities, invasiveness or lack of necessary support systems, a patient may not be able to undergo surgery.
As a prior orthopedic nurse, I have seen many patients undergo knee replacement surgery and steroid injections. By the time patients get surgery, many have been dealing with pain for years and COOLIEF could be an option for these patients. COOLIEF should also be presented as another option for patients over steroid injections. It is minimally invasive and if effective it can help relieve knee pain, increase functionality, and decrease the need for pain medication.
Due the the recent FDA approval of the treatment, not many studies are out there. I think my opinion about the use of COOLIEF would be strengthen if there were more research. Therefore, I would like to see more studies on the effectiveness and pain management duration.  Studies should also be done independently and not sponsored by HYH.

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1. Achiever

2. Learner

3. Discipline

4. Harmony

5. Consistency

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Abraham (Arranger) can organize and figure out the pieces and resources we need for marketing and gathering research that supports the use of COOLIEF. He is efficient and flexible, and will be able to adapt to help change tasks for team members to stay on track.
Carter (Communication) will be good at presenting COOLIEF to hospitals, clinics, and at conventions. He’s entertaining, easy to talk to, and has a great presence. These qualities will also help us build relationship with communities.
Emily (Empathy) will help create trust between team members but also between the community and the COOLIEF team. She would be good at customizing COOLIEF approaches and products to different patient populations.
Faith (Futuristic) can help the team look into the future and think about how to take COOLIEF further to help more patients. COOLIEF currently is only FDA approved for knee pain, Faith can help inspire the team to create products that can reach greater patient populations (shoulder pain, back pain, hip pain, etc.).
Sheila (Strategic) would be good at finding ways to proceed when the team hits a milestone. Since COOLIEF is a new product, issues may arise and Sheila would be able to help the team quickly identify patterns and find alternative ways for the team to proceed.

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Centers for Disease Control and Prevention. (2019). Osteoarthritis. Retrieved from https://www.cdc.gov/arthritis/basics/osteoarthritis.htm

Davis, T., Loudermilk, E., DePalma, M., Hunter, C., Lindley, D., Patel, N., ... & Buvanendran, A. (2018). Prospective, multicenter, randomized, crossover clinical trial comparing the safety and effectiveness of cooled radiofrequency ablation with corticosteroid injection in the management of knee pain from osteoarthritis. Regional Anesthesia and Pain Medicine, 43(1), 84-91.
doi: 10.1097/AAP.0000000000000690

Medgadget. (2017, May 1). COOLIEF cooled radiofrequency cleared to relieve pain in osteoarthritic knees. Retrieved from https://www.medgadget.com/2017/05/coolief-cooled-radiofrequency-cleared-relieve-pain-osteoarthritic-knees.html

MyCOOLIEF. (n.d.). About COOLIEF. Retrieved from https://www.mycoolief.com/about

PR Newswire. (2017, April 20). FDA clears Halyard Health’s COOLIEF for the management of osteoarthritis knee pain. Retrieved from https://www.prnewswire.com/news-releases/fda-clears-halyard-healths-coolief-for-the-management-of-osteoarthritis-knee-pain-300442628.html