SAN DANIELE DEL FRIULI, Italy, April 20, 2021 /PRNewswire/ — LimaCorporate is proud to announce the first surgery performed in the SMR Stemless Reverse Shoulder System Investigational Device Exemption (IDE) study. This randomized, multi-center comparative clinical trial is currently evaluating the safety and effectiveness of the SMR Stemless Reverse Shoulder System compared to the SMR Reverse Shoulder System, in total reverse shoulder arthroplasty. FDA approval of the SMR Stemless Reverse Shoulder System IDE was obtained in November 2020 and patient enrollment began in April 2021. The study aims to enroll 200 patients at eight U.S. investigational sites with two-year follow-up.
LimaCorporate aims to continuously address the evolving needs of the orthopedic market with innovative solutions while guaranteeing the highest clinical standards to ensure patients safety and implant effectiveness. The SMR Stemless Reverse Shoulder is currently approved in Europe, Mexico and selected APAC markets, and is an innovative, bone-sparing shoulder arthroplasty solution for the treatment of rotator cuff deficiencies.
Stemless implants represent a growing trend for the U.S. market, however, there are currently no stemless reverse implants cleared for use by the FDA. LimaCorporate’s IDE study on SMR Stemless Reverse System is a pivotal first step to address this unmet need in the U.S. shoulder arthroplasty market. The SMR Stemless Reverse also represents a new concept in joint articulation by inverting the traditional bearing materials and combining a polyethylene glenosphere with a metal humeral liner, in addition to a stemless humeral device.
The first surgery with the SMR Stemless Reverse was performed by Dr. Kevin Setter at Upstate Orthopedics in Syracuse, New York. Dr. Setter stated that “The case went really well and I’m very satisfied with the outcome. The streamlined instrumentation made the surgical steps easy to follow and Trabecular Titanium on the proximal taper ring of the Stemless core gave good initial stability and fixation on humeral bone. Also, the polyethylene glenosphere, which has been available for many years outside of the US, is an innovative solution for U.S. reverse shoulder arthroplasty procedures.”
Luigi Ferrari, CEO of LimaCorporate, added, “The first successful surgery of the SMR Stemless Reverse in the clinical trial of the IDE represents another major milestone after the FDA approval we received at the end of 2020. This shows that we are on our way to making a great contribution to the U.S. orthopedic market with a device that will target the trending needs of reverse shoulder arthroplasty.”
LimaCorporate is a global orthopedics company, focused on digital innovation and tailored hardware, which advances patient centered care. Its pioneer technological solutions are developed to empower surgeons, and to improve patient outcomes from joint replacement surgery. Its primary focus is on providing reconstructive and custom-made orthopedic solutions to surgeons, enabling them to improve the quality of life of patients by restoring the joy of movement.
Headquartered in Italy, the company operates directly in over 20 countries around the world. LimaCorporate offers products ranging from large joint revision and primary implants, to complete extremities solutions, including fixation.
For additional information on the Company, please visit: limacorporate.com
Source: Limacorporate S.p.A.