Iovera

The iovera° system utilizes extreme cold to ablate tissue during surgical procedures and create lesions in peripheral nervous tissue, effectively blocking pain signals. It is specifically designed for relieving pain and symptoms linked to knee osteoarthritis for up to 90 days. Please note that the iovera° system is not intended for treating central nervous system tissue. Additionally, the "1x90" Smart Tip configuration, consisting of a single 90 mm long needle, can aid in pinpointing the target nerve location through electrical nerve stimulation conducted by a separate nerve stimulator.

Contraindications

The iovera° system is contraindicated for individuals with the following conditions:

• Cryoglobulinemia (thickening of blood upon cold exposure).
• Paroxysmal cold hemoglobinuria (blood in urine upon cold exposure).
• Cold urticaria (skin rash triggered by cold exposure).
• Raynaud's disease (narrowing of blood vessels in hands and feet upon cold exposure).
• Open and/or infected wounds at or near the treatment site.

Adverse Reactions

Patients undergoing treatment with the iovera° system, a needle-based therapy, may encounter various reactions, which can include:

• Bruising
• Swelling
• Inflammation
• Redness
• Localized pain
• Tenderness
• Altered sensation at the application site

Following the instructions outlined in the User Guide for the device can assist in minimizing or averting the following reactions:

In the treated area(s):

• Skin damage due to exposure to cold or heat
• Changes in skin pigmentation (darkening or lightening)
• Formation of skin dimples

Outside the treated area(s):

• Impairment of normal muscle function or movement

"I wanted to let you know about my iovera° experience. My procedure was done approximately seven months ago. The day of the procedure I practically danced out of the office. In fact, I remember asking Bill sometime during the procedure if he was finished because that's how quickly I could feel relief. When I got home, I immediately experimented with two things I was unable to do since the surgery. The first was bending the knee completely. But the second was more amazing, I was able to cross my left knee over my right knee for the first time in 12 years without any pain at all (a miracle as far as I was concerned). For me, these two things were beyond my expectations. I would recommend to anyone who might be thinking of trying iovera° to go ahead and give it a try, I think you will be amazed at the results. From the minute Dr. Press told me about it, I was a go. If you have any questions beyond what your doctor told you, you can reach me through their office."

-Carol B. 3/21/2022

"Firstly, thank you for the personal and professional courtesies extended to me during the course and scope of recent knee replacement surgeries and ancillary treatments. I have little doubt that the same personal attention is rendered to each and every patient but being made to feel special is an aspect that is sorely needed in all aspects of patient / practitioner relationships. You both excelled in that respect. As regards the iovera° procedure, like most non-medical people the topic was one of many in which had little or no working knowledge prior to the introduction prior to surgery. From a common-sense standpoint it makes sense that if some preventative protocol could be undertaken to impact, the pains threshold resulting from surgery, it should become a routine inclusion in the overall patient treatment. Prior to undertaking the full procedure, I did some research with people I know with first-hand experience. The results of the enquiries were quite off-putting with horror stories about excruciating pain and lingering aftereffects accompanied by massive pain. Two “testimonials” reflected pain requiring medications as far as a year out. Their immediate post-op pain was described as totally intolerable. I was prepared for the worst but had been given hope that the IOVERA treatments was everything it was expected to be. I certainly was not disappointed. From the first few minutes’ regaining conscientiousness to this minute the pain never exceeded a level at which I needed to resort to the OXY prescription written for expected pain control. At nearly four weeks post-op I only resorted to use of one Oxy but that was a consequence of my overachieving personality where I pushed the envelope and experienced nontraditional pain levels. I would heartily recommend to anyone requiring knee replacement surgery to avail themselves of the iovera° treatment if it is suggested by their medical team. Thank you again for your caring practice. "

-Michael 3/31/2022

"I am writing this email concerning the above procedure that I received prior to surgery replacing my right knee on April 5, 2022. The above procedure or nerve block was performed prior to my operation. Dr. Martin explained that the procedure would block the nerves in the area of my right knee which would result in less post-operation pain in my right knee area which would also result in my having to take less medication. The procedure had no adverse effect on my ability to walk. Subsequent to the surgery, I had pain in my right knee for about a day and a half, which pain was greatly reduced in the ensuing days. I ceased taking oxycodone after 4 days. In about a week I virtually had no pain in my knee. I spoke to other individuals who had a similar operation who stated that they did not have this procedure and had pain in their knees for a longer period of time. I am of the belief that the nerve block greatly reduced my pain and for the need to take medication as it pertained to postoperative pain and based upon my experience, I recommend that individuals who are contemplating a knee replacement have this procedure."

-Alexander S. 4/21/2022

"Having undergone the knee replacement surgery on April 26th, I have come to realize and appreciate the importance of the preparatory iovera° treatment you performed on April 6th. In my particular case, the advance and longer-term block of the nerves around the knee provided by this treatment resulted in reduced post-surgery pain. Other than Tylenol in the first 3-4 days, there was no need for any of the prescribed pain medication. Also, think it resulted in an earlier start with meaningful physical therapy. Overall, I just wanted to say thanks to you and Liz for recommending and administering this iovera° treatment."

-Frank S 5/20/2022

• Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016;23(3):523-528.
• Hsu M, Stevenson FF. Wallerian degeneration and recovery of motor nerves after multiple focused cold therapies. Muscle Nerve. 2015;51(2):268-275.