FDA Authorizes Marketing of MISHA
FDA Authorizes Marketing of MISHA™
Knee System for People Suffering from Knee Osteoarthritis
Moximed, a manufacturer of medical devices for the treatment of people with osteoarthritis of the knee (OA), announced that the US Food and Drug Administration (FDA) has obtained marketing authorization for the MISHA™ Knee System, a implantable shock absorber (ISA) for the knee.
The MISHA Knee System is indicated to treat people with medial knee OA who failed to find relief from non-surgical or surgical treatment, continue to experience pain that interferes with daily activities, and are ineligible for, or unwilling to undergo, joint replacement due to age or absence of advanced OA.
Moximed utilized the clinically established benefits of load reduction on diseased joints to design the MISHA Knee System. Implanted during an outpatient-compatible procedure, the MISHA Knee System demonstrated superiority over high tibial osteotomy (HTO), a well-established surgery with decades of demonstrated clinical results.
Osteoarthritis (OA) is a common, debilitating condition.
Knee OA develops when the joint’s natural shock absorbers, cartilage and meniscus, no longer cushion the joint from daily activities, leading to chronic pain and activity limitation.
Many people with mild to moderate OA are otherwise healthy, in their prime working years, and have busy lives to live.
For these patients, total knee replacement is a reluctant option, as it is an end-stage treatment for end-stage disease. OA patients without end-stage disease seek options that preserve their knee, activity level, and quality of life.
Reducing weight on painful osteoarthritic joints is known to reduce pain and improve function. The MISHA™ Knee System being developed is the first implantable shock absorber that reduces weight on the knee joint with every walking step, easing pain, preserving function, and possibly delaying joint replacement surgery. The implant is placed on the medial knee and moves with the natural joint, reducing about 30% of the peak force on the knee with every walking step.
MISHA Knee System is implanted during an outpatient procedure; it’s the first and only device of its kind for people with symptomatic knee OA.