SAN DANIELE DEL FRIULI, Italy, April 20 , 2021 / PRNewswire / – LimaCorporate is proud to announce the successful first surgery for the IDE (Investigational Device Exemption) study for the SMR Stemless Reverse Shoulder System. This randomized, multicenter, comparative clinical study is currently evaluating the safety and effectiveness of the SMR Stemless Reverse Shoulder System in comparison to the SMR Reverse Shoulder System in total inverse shoulder arthroplasty. The company received the FDA’s IDE for the SMR Stemless Reverse Shoulder System in November 2020 . Patient registration began in April 2021 . As part of the study 200 patients are to be treated at eight test centers in the USA . The follow-up period is two years.
The goal of LimaCorporate is to meet the constantly evolving needs in orthopedics with innovative solutions while guaranteeing the highest clinical standards to ensure patient safety and the effectiveness of the implants. The SMR Stemless Reverse Shoulder System is currently approved in Europe, Mexico, and selected APAC markets. It is an innovative, bone-sparing shoulder endoprosthesis implant that is indicated for the treatment of patients with a severely defective rotator cuff.
Stemless implants are a growing trend in the US market, however, no stemless inverse implants are currently approved by the FDA. LimaCorporate’s IDE study on the SMR Stemless Reverse System is a critical first step in addressing this unmet need in the US shoulder prosthesis market. The SMR Stemless Reverse also represents a new concept in joint articulation; it reverses the traditional stock materials and combines a polyethylene glenosphere with a metallic humeral liner in addition to a stemless humeral implant.
The first operation with the SMR Stemless Reverse System was performed by Dr. Kevin Setter at the Upstate Orthopedics Clinic in Syracuse, New York . Dr. Setter explained: “The procedure went really well and I am very happy with the result. The streamlined instruments made the surgical steps easy to carry out and the trabecular titanium on the proximal conical ring of the stemless core immediately offered good stability and fixation on the humeral bone. The polyethylene glenosphere, which has been available outside the US for many years , is also an innovative solution for inverse shoulder arthroplasty in the US .”
Luigi Ferrari , CEO of LimaCorporate , added, “The first successful surgery using the SMR Stemless Reverse System in this IDE clinical trial marks another major milestone after we received FDA approval in late 2020. This shows that we are well on the way to making an important contribution to the orthopedic market in the USA with our implant, which is geared towards the increasing demand for inverse shoulder arthroplasty.”
Information on LimaCorporate
LimaCorporate is a global orthopedic company that focuses on digital innovation and bespoke hardware, advancing patient-centered care. Its breakthrough technological solutions are designed to empower surgeons and improve patient outcomes in joint replacement surgery. The main focus is on providing surgeons with reconstructive and bespoke orthopedic solutions that improve patients’ quality of life by bringing them back the joy of movement.
The company, headquartered in Italy, operates in over 20 countries around the world. LimaCorporate offers products that range from major joint revisions and primary implants to complete extremities including restraint.
Further information on the company can be found at: limacorporate.com
SOURCE Limacorporate SpA