Active Implants announced two-year results of the MERCURY study, showing that the company’s NUsurface® Meniscus Implant provides statistically superior pain relief beginning at six months compared to non-surgical therapy.
The NUsurface Implant is the first “artificial meniscus” to be marketed in Europe and is currently under review by FDA. The medial meniscus replacement mimics the function of the natural meniscus and treats pain by redistributing loads transmitted across the knee joint. It was granted a Breakthrough Device Designation from the FDA in 2019.
The MERCURY Study is the longest and most extensive study of a meniscus implant in the world, enrolling 242 patients experiencing persistent knee pain after a previous meniscectomy: 176 were treated with the NUsurface Implant and 66 with non-surgical therapy. Results of the study include:
- 84% of patients treated with the NUsurface Implant experienced a 10-point improvement from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain, which is considered the minimum clinically relevant improvement in pain and function.
- 89% of patients who received the NUsurface Implant completed 24 months of follow-up.
- Patients with replacement implants achieved superior results the second time; 70% of patients used one implant and 20% received a replacement implant.
- Obese and older patients had the highest response rates.
- MRI evidence showed the NUsurface Implant may preserve femoral cartilage, while the control patients showed evidence of significant cartilage deterioration.
The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. It is made from medical grade polymer and does not require fixation to bone or soft tissues. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is currently marketed in Belgium, Germany, Italy, the UK and Israel.
Source: Active Implants