Five Things Clinical Studies Are Showing about AxioMed’s Next-Generation Freedom® Total Disc Replacement

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Newly Released Data Shows Patients Experience Minimal Pain With Freedom Discs

Freedom Lumbar Disc

The Freedom Lumbar Disc provides better pain relief than anterior lumbar interbody fusion (ALIF) according to an EU clinical study.

AxioMed, LLC (http://www.axiomed.com) announced today five key statistics from clinical studies about the AxioMed Freedom® total disc replacement technology. The following data is gathered from European clinical studies published in peer-reviewed medical journals and Orthopedic Meeting Proceedings.

1. In an EU clinical study, after two years, half of patients with a lumbar disc had less than 10% disability score and reported less than 1/10 on the pain scale. [1]

  • In the same EU clinical study of fifty patients who had the Freedom® Lumbar Disc implanted, at 24 months, half of the patients had an ODI (Oswestry Disability Index) of ≤ 10%. [2]
  • With an average pre-op score of 7/10 VAS low back pain, half of the patients who had the Freedom Disc implanted had a VAS Low Back Pain ≤ 1 cm 24 months post-op. [3]

2. The Freedom Lumbar Disc provides better pain relief than anterior lumbar interbody fusion (ALIF) according to an EU clinical study. [4]

  • In patients with disc degeneration, viscoelastic total disc replacement showed a higher likelihood for the achievement of clinically relevant back and leg pain relief than anterior lumbar interbody fusion (ALIF). [5]

3.There have been no device failures noted in the clinical literature for either the Freedom Cervical or Lumbar Discs at the time of this publication.

  • The Freedom Discs have been implanted in hundreds of patients globally.

4.The Freedom® Lumbar Disc performed better than competitor TDRs. [6]

  • The Freedom Lumbar Disc had statistically significant better health status scores at 3-6 months, 1 year and 2 year intervals. [7]
  • The Freedom Lumbar Disc had statistically significant better VAS Low Back Pain Scores at 3-6 months, 1 year and 2 year intervals, despite having higher pre-op VAS Low Back Pain Scores. [8]
  • Freedom Lumbar Disc patients were on average ten years older than other TDR patients, had higher percentage of 2 level cases (66% Freedom Lumbar Disc versus 15% other TDR), higher pre-op low back pain scores (76.0 Freedom Lumbar Disc versus 69.1 other TDR) and higher pre-op leg pain scores (68.8 Freedom Lumbar Disc versus 53.5 other TDR). [9]

5.The Freedom Disc is the first device to restore a normal center of rotation to patients. [10]

  • The Freedom Disc is the first device to show correlation of center of rotation to clinical outcomes at 2 years. Patients with normal device placement are 7 times more likely to achieve significant clinical improvement (15 point ODI improvement) than those with anterior placed device. [11]

About AxioMed

Founded in 2001, AxioMed (http://www.axiomed.com) began its journey of exhaustively proving the Freedom® Disc, a total disc replacement technology, through research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.

Media Contact: caitlinlubinski(at)kicventures(dot)com

Citations

1. Rischke B, Ross RS, Jollenbeck BA, Zimmers KB, Defibaugh ND. Pre-Clinical and Clinical Experience with a Viscoelastic Total Disc Replacement. SAS Journal 5 (4); pp. 97-107, 2011.
2. Ibid.
3. Ibid.
4. Rischke B, Zimmers K, Smith E. Viscoelastic Disc Arthroplasty Provides Superior Back and Leg Pain Relief in Patients with Lumbar Disc Degeneration Compared to Anterior Lumbar Interbody Fusion. International Journal of Spine Surgery 9; July 2015.
5. Ibid.
6. Rischke B, Kammermeier V, Runkel M, Zimmers K, Kuras J. Clinical Outcomes for a Viscoelastic Total Disc Replacement Compared to Other Total Disc Replacements in the SWISSspine Registry. Presented at the International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting, Barcelona, Spain, March 2012.
7. Ibid.
8. Ibid.
9. Ibid.
10. Newton Ede M, Ross ERS, Rischke B, Joellenbeck B, Hipp J, Zimmers K. An Association Between the Center of Rotation and Clinical Outcome in Patients Implanted with a Viscoelastic Total Disc Replacement. Proceedings of the British Orthopaedic Association Congress, 2011.
11. Ibid.

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Caitlin Lubinski
HealthTech Ventures Network
since: 07/2014
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