Clinical Data

The Menaflex™ collagen meniscus implant (formerly CMI^®) product has been the subject of numerous clinical studies, scientific presentations, and published papers.  The clinical studies show the Menaflex scaffold is safe and supports growth of new tissue resulting in improvements from pre-surgery in pain, function and activity level.  Published literature indicates that patients with chronic meniscus injuries had fewer meniscus symptom related additional surgeries than patients receiving a partial meniscectomy alone.

The Menaflex implant facilitates the growth of the patient’s own tissue.

• Meniscus does not regenerate on its own.
• The U.S. multicenter clinical trial reported a 97% tissue increase in chronic patients.
• Tissue growth was documented by re-look arthroscopy one year following the procedure.
• The new tissue has longevity based on feasibility study patients’ re-look procedure at more than 5 years.

The meniscus symptom related 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 levels¹.

• 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 regaining lost activity level.  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 Although the satisfaction levels were higher the difference was not statistically signifcant.