Results from the pivotal Calypso Study of Moximed’s MISHA™ Knee System, an implantable shock absorber (ISA) for the treatment of knee osteoarthritis, demonstrated superiority of the primary endpoint and demonstrated a clinically significant reduction in pain scores and improvement in function scores for participants receiving the MISHA Knee.
Designed to relieve pain, preserve function, and offer a treatment option that could potentially delay arthroplasty, MISHA is an implantable shock absorber developed to unload on the knee with every walking step.
The Calypso Study, a prospective and multicenter clinical study that enrolled 81 subjects, evaluated the safety and effectiveness of the MISHA Knee System, compared to high tibial osteotomy (HTO), when used to treat symptomatic osteoarthritis of the medial compartment of the knee.
MISHA met its primary endpoint and was found to be superior to high tibial osteotomy at two years. The system demonstrated an 85.6% composite success rate compared to that of HTO (65.5%). Moximed’s ISA continued to demonstrate superiority on all secondary endpoints, including the time to full weight bearing.
The MISHA Knee System has the potential to delay joint replacement in certain patients.
Source: Moximed
Results from the pivotal Calypso Study of Moximed's MISHA™ Knee System, an implantable shock absorber (ISA) for the treatment of knee osteoarthritis, demonstrated superiority of the primary endpoint and demonstrated a clinically significant reduction in pain scores and improvement in function scores for participants receiving the MISHA Knee.
...
Results from the pivotal Calypso Study of Moximed’s MISHA™ Knee System, an implantable shock absorber (ISA) for the treatment of knee osteoarthritis, demonstrated superiority of the primary endpoint and demonstrated a clinically significant reduction in pain scores and improvement in function scores for participants receiving the MISHA Knee.
Designed to relieve pain, preserve function, and offer a treatment option that could potentially delay arthroplasty, MISHA is an implantable shock absorber developed to unload on the knee with every walking step.
The Calypso Study, a prospective and multicenter clinical study that enrolled 81 subjects, evaluated the safety and effectiveness of the MISHA Knee System, compared to high tibial osteotomy (HTO), when used to treat symptomatic osteoarthritis of the medial compartment of the knee.
MISHA met its primary endpoint and was found to be superior to high tibial osteotomy at two years. The system demonstrated an 85.6% composite success rate compared to that of HTO (65.5%). Moximed’s ISA continued to demonstrate superiority on all secondary endpoints, including the time to full weight bearing.
The MISHA Knee System has the potential to delay joint replacement in certain patients.
Source: Moximed
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.