LimaCorporate Completes First-Ever Implant in IDE Study of SMR Stemless Reverse Shoulder System

Sant'Ilario del Friuli, Italy, April 20, 2021 /PRNewswire/ -- LimaCorporate is proud to announce that the first surgical procedure has been completed in its Investigational Device Exemption (IDE) study of the SMR Stemless Reverse Shoulder System. This randomized, multicenter comparative clinical trial is currently evaluating the safety and efficacy of the SMR Stemless Reverse Shoulder System in total shoulder arthroplasty, compared with the SMR Reverse Shoulder System. The FDA approved the IDE for the SMR Stemless Reverse Shoulder System in November 2020, and patient enrollment began in April 2021. The study aims to enroll 200 patients across eight investigational sites in the United States, followed by a two-year follow-up period.

LimaCorporate aims to continuously meet the evolving demands of the orthopedic market through innovative solutions, while upholding the highest clinical standards to ensure patient safety and implant efficacy. The SMR Stemless Reverse Shoulder, currently approved in Europe, Mexico, and select Asia-Pacific markets, is an innovative bone-preserving shoulder arthroplasty solution for the treatment of rotator cuff deficiencies.

Although stemless implants represent a growing trend in the U.S. market, there are currently no FDA-approved stemless reverse shoulder implants available. Lima Corporate’s Investigational Device Exemption (IDE) study for the SMR Stemless Reverse System is a critical first step in addressing the unmet need in the U.S. shoulder arthroplasty market. In addition to the stemless humeral component, the SMR Stemless Reverse introduces a novel concept of articulation by departing from traditional bearing materials and incorporating a polyethylene sphere with a metallic humeral liner.

The first SMR Stemless Reverse procedure was performed by Dr. Kevin Setter at the Orthopedic Center in northern Syracuse, New York. Dr. Setter stated, “The surgery went very well, and I am highly satisfied with the outcome. The simplified instrumentation makes the surgical steps easy to follow, and the trabecular titanium on the proximal tapered ring of the stemless core achieves good initial stability and fixation in the humerus. Furthermore, the polyethylene sphere has been used outside the United States for many years and represents an innovative solution for reverse shoulder arthroplasty in the U.S.”

Luigi Ferrari, CEO of LimaCorporate, added, “The first successful surgery with the SMR Stemless Reverse in the IDE clinical trial marks another significant milestone following our FDA approval in late 2020. This demonstrates that we are making a substantial contribution to the U.S. orthopedic market with a device designed to meet the growing demand for reverse shoulder arthroplasty.”