UDINE, Italy, Nov. 19, 2020 /PRNewswire/ -- LimaCorporate is proud to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational Device Exemption (IDE) to start the clinical trial of the SMR Stemless Reverse Shoulder System.
The FDA approval allows LimaCorporate to start a randomized, multi-center comparative clinical trial on the SMR Stemless Reverse in the U.S. to evaluate its safety and effectiveness compared to the SMR Reverse Shoulder System, in total reverse shoulder arthroplasty. The trial will enroll 200 patients with a two-year follow-up and is planned to start in Q1 2021 with seven U.S. investigational sites involved. SMR Stemless Reverse system has been approved in Europe, Mexico and selected APAC markets including Australia, New Zealand and South Korea.
SMR Stemless Reverse, part of the SMR System, is an innovative bone sparing shoulder arthroplasty implant indicated for the treatment of patients with a grossly deficient rotator cuff, with the advantage of preserving humeral bone, allowing smoother revision procedures, and preventing stem-related complications. According to a recent market report published by Med Device Online dated April 11th, 2018, the use of stemless implants in shoulder arthroplasty is expected to exceed the use of stemmed implants in Europe by 2025. It has also been reported that the future outlook for the U.S. market shows a similar growing trend of stemless implants.
SMR Stemless Reverse Shoulder System is compatible with the previously FDA cleared SMR Reverse Shoulder components currently on the market since 2011. The Stemless Core features Trabecular Titanium (TT), LimaCorporate's 3D printed leading technology, and a reverse liner on the humeral side. On the glenoid side, the polyethylene glenosphere represents an innovative solution in reverse shoulder arthroplasty because the inversion of the materials avoids the scapular notching phenomenon, frequently associated with this type of surgery.
Luigi Ferrari, CEO of LimaCorporate, commented, "We are very excited about the approval of the IDE study for the SMR Stemless Reverse. It is a major and strategic achievement for LimaCorporate, allowing us to start a clinical trial on a device that addresses the needs of reverse shoulder arthroplasty in the U.S. market. The IDE study demonstrates LimaCorporate's focus on improving patients' lives through constant research and innovation, empowering and assisting surgeons to restore the emotion of motion in their patients."
Michael Bauer, Partner at EQT and Co-Head of EQT's Healthcare Sector Team, added, "The IDE approval is a major milestone as LimaCorporate remains committed to providing surgeons innovative solutions while upholding the highest clinical standards to ensure patient safety and implant effectiveness."
LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate's product range includes large joint revision and primary implants and complete extremities solutions including fixation.