Sam Brusco, Associate Editor03.01.23
Moximed has released a peer-reviewed article about its MISHA knee system, an implantable shock absorber (ISA) for the knee.
Two-year pivotal IDE study results and superiority of the Calypso study primary endpoint were published in the journal Cartilage. MISHA was found to be superior to high tibial osteotomy (HTO) against a two-year composite endpoint, demonstrating pain relief, functional improvement, and positive safety profile in medial knee osteoarthritis (OA) patients.
Major findings from the study include:
“The MISHA Knee System achieved its IDE study primary endpoint with superiority. The investigators and I are pleased to report complete details of the clinical study, which was designed specifically to meet a rigorous FDA hurdle,” David R. Diduch, MD, the A.F. Voshell Professor of Sports Medicine, Department of Sports Medicine, University of Virginia, told the press. “The results demonstrated that nearly all the patients who received the MISHA Knee System experienced clinically meaningful pain relief at two years, and the safety profile of the device and procedure were comparable to a well-established surgical control. I anticipate many surgeons and patients will be excited to learn about this technology.”
Two-year pivotal IDE study results and superiority of the Calypso study primary endpoint were published in the journal Cartilage. MISHA was found to be superior to high tibial osteotomy (HTO) against a two-year composite endpoint, demonstrating pain relief, functional improvement, and positive safety profile in medial knee osteoarthritis (OA) patients.
Major findings from the study include:
- 90.5% of U.S. patients were discharged in under 24 hours, and the study population returned to full weight-bearing without assist devices by an average 13 days.
- 95.8% of patients treated with an ISA reported clinically meaningful pain relief at two years.
- At 24 months, patients reported an average of 76% reduction in pain and 74% improvement in function compared to baseline levels.
- 95% of ISA patients were free from an endpoint safety event, and 100% of ISA devices were free from mechanical failure.
“The MISHA Knee System achieved its IDE study primary endpoint with superiority. The investigators and I are pleased to report complete details of the clinical study, which was designed specifically to meet a rigorous FDA hurdle,” David R. Diduch, MD, the A.F. Voshell Professor of Sports Medicine, Department of Sports Medicine, University of Virginia, told the press. “The results demonstrated that nearly all the patients who received the MISHA Knee System experienced clinically meaningful pain relief at two years, and the safety profile of the device and procedure were comparable to a well-established surgical control. I anticipate many surgeons and patients will be excited to learn about this technology.”