The medical device company Moximed announced that its MISHA Knee System has been granted marketing authorization by the U.S. Food and Drug Administration (FDA). Moximed explained that the MISHA Knee System is designed to provide pain relief and improve joint functionality in patients with medial knee osteoarthritis who did not achieve adequate symptom reduction after undergoing nonsurgical or surgical intervention through shock absorption and knee preservation. In a recent clinical study, published by Diduch et al in Cartilage, researchers found the MISHA Knee System to be safe and potentially more effective than high tibial osteotomy and reported that the technology met its superiority composite endpoint. “With the FDA’s clearance of the MISHA Knee System, millions of [patients] with symptomatic knee [osteoarthritis] will now have an opportunity to achieve high levels of pain relief, enjoy the lifestyle and activities that are important to them, and preserve the option for primary knee arthroplasty in the future,” concluded Anil Ranawat, MD, Chief of the Hip and Knee Division at the Sports Medicine Institute at the Hospital for Special Surgery in New York.
May 25, 2023