Medical device company Moximed has reported data from the pivotal Calypso Study of its MISHA Knee System.
An implanted shock absorber (ISA), the MISHA Knee System has been designed to treat knee osteoarthritis.
It is intended to ease pain, maintain function and provide a treatment option that is capable of delaying arthroplasty.
The multicentre, prospective clinical study, which involved 81 participants, was designed to assess the effectiveness and safety of the MISHA Knee System against high tibial osteotomy (HTO) for the treatment of symptomatic osteoarthritis.
In the study, the MISHA Knee System showed the superiority of its primary endpoint, demonstrating reduced pain scores and improved function scores for participants.
Moximed CEO Anton Clifford said: “In our investigational device exemption (IDE) study, the MISHA Knee System was compared to the high standard set by high tibial osteotomy, a well-established orthopedic procedure.
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“To demonstrate superiority against an established procedure, with proven results, is a great outcome for patients.”
The company noted that the system achieved its primary endpoint and was found to be superior to high tibial osteotomy (HTO) at two years.
In the Calypso Study, the MISHA Knee System showed a composite success rate of 85.6%, compared to 65.5% by HTO.
It also showed superiority on all secondary endpoints of the study, including improvement of Knee injury and Osteoarthritis Outcome Score (KOOS)-derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function ratings at both three and 24 months, as well as time to complete weight bearing.
Placed on the medial knee, the MISHA implant moves with the natural joint to lower peak forces on the knee by more than 30% with every walking step.