The Menaflex™
collagen meniscus implant (formerly
CMI) product has been
the subject of numerous clinical studies1,
scientific presentations, and
published papers. The results of
the clinical studies show the Menaflex
scaffold supports growth of new tissue,
reduces the likelihood of additional
meniscus surgery, improves patient
satisfaction and activity levels, and is
safe.
The Menaflex procedure facilitates the
growth of the patient's own tissue.
-
Meniscus does not regenerate on its own.
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The U.S. multicenter clinical trial reported a 97% tissue increase in chronic patients.
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Tissue growth was documented by re-look arthroscopy one year following the procedure.
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The new tissue has longevity based on feasibility study patients' re-look procedure at more than 5 years.
The re-operation rate for chronic
patients was nearly 3 times lower for
Menaflex patients after four years.
Menaflex patients with chronic meniscus injuries reported higher satisfaction levels.
- Satisfaction was statistically correlated with pain, Lysholm, and Tegner activity scores.
- Patient satisfaction reflects each patient's desired outcome.
Within the chronic group, Menaflex
patients had a significant increase in
return to activity.
The Menaflex procedure is safe.
- There were no unanticipated adverse events associated with the device.
- Re-look biopsies indicate no adverse histological effect.
- Immunologic studies indicate no significant immune response.
1 Data on file, ReGen
Biologics.
