Published clinical experience and 2-year follow-up with AxioMed’s one-piece viscoelastic cervical total disc replacement
January 2, 2021
Background : The purpose of this study is to present clinical outcome data from a 2-year post-market study of a viscoelastic one-piece cervical total disc replacement (TDR) in Europe.
​
Methods : Thirty-nine patients were implanted at five surgical sites in an European post-market clinical study. Clinical outcomes included improvement of neck disability index (NDI) and visual analog scale scores for neck and arm pain from baseline to 2-year follow-up, neurological examinations, patients view on the success of surgery, complications, and subsequent surgical interventions.
​
Results : Thirty patients had the Freedom® Cervical Disc (FCD) implanted at a single level, and nine patients were implanted at two adjacent levels. The population had a similar distribution of male [20] and female [19] subjects, with a mean age of 45 years. All self-administered outcome measures showed significant clinically important improvements from baseline to the 2-year follow-up. Mean preoperative NDI score improved from 48% to 20%, 13%, 8%, 6% and 4% at 6 weeks, 3, 6, 12, and 24 months, respectively. Average preoperative visual analog scale (VAS) scores of the neck, right and left arm pain intensity and frequency showed significant improvement. All neurological outcome measurements showed immediate improvement from preoperative values and continued improvement throughout 2 years follow-up. From pre-op to 24 months, neurological deficits declined in the population from 21% to 6% for reflex function, 62% to 17% for sensory function, and 38% to 3% for motor function. No patients experienced a deterioration in any measured outcomes compared with the preoperative situation. Patient satisfaction increased over 2 years post-op, with 83% of patients responding that they would "definitely" choose to have the same treatment for their neck/arm condition and another 11% responding that they would "probably" choose to have the same treatment.
​
Conclusions : The FCD performs as expected in patients with single-level and two-level degenerative disc disease. In this early clinical experience with the FCD, patients experienced similar pain relief and lower disability at 2 years follow-up compared to both articulating and viscoelastic TDRs.
​
About AxioMed
AxioMed was founded in 2001 by surgeons at Cleveland Clinic and engineers who previously worked with Dr. Art Steffee and Acroflex viscoelastic disc replacement. The current AxioMed disc comprises of a proprietary silica-based viscoelastic material proven in extensive biomedical/biocompatible testing to mimic the human disc in all planes and 50+ years of longevity testing. The viscoelastic material is radiolucent and thus X-ray and MRI compatible. Over 800 discs have been implanted worldwide with zero device failures or revisions. It is the only viscoelastic lumbar disc to complete a USA IDE clinical study with 10+ years of follow-up.AxioMed is also the only company pursuing 3 level Cervical Disc and Lateral Lumbar Disc IDE clinical studies for FDA clearance. AxioMed has years of international experience with positive data showing its effectiveness in multilevel cervical and lumbar disc replacement surgeries (up to 4 levels).
https://www.axiomed.com/
About KICVentures Group
Investing in healthcare since 2000, makes KICVentures an experienced healthtech investment holding company focused on spine surgery. We partner with key physicians to identify niche problems affecting patients then acquire or invent differentiated technology solutions with our capital and partner with co-investors. An example is the MANTIS device for minimally invasive screw fixation acquired by Stryker as a 100X return on investment.
Our vision is to lead in healthtech. We own $1 Billion+ in assets and generated $250+ million in revenues. With years of EBITDA profitability, offset from buyout acquisitions such as AxioMed and NanoFuse, we target profitability from exits in Q4 2021 - 2022, IPOs by 2023 and FDA clearance of the AxioMed disc in 2021.
http://www.KICVenturesGroup.com