LimaCorporate Receives FDA IDE Approval for SMR Stemless Reverse Shoulder System Clinical Trial

Udine, Italy, Nov. 19, 2020 /PRNewswire/ -- LimaCorporate is proud to announce that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application to initiate clinical trials for the SMR Stemless Reverse Shoulder System.

FDA approval allows LimaCorporate to initiate a randomized, multicenter, comparative clinical trial in the United States for the SMR Stemless Reverse system, aimed at evaluating its safety and efficacy in total reverse shoulder arthroplasty compared to the SMR Reverse Shoulder System. The trial will enroll 200 patients with a two-year follow-up period and is scheduled to commence in the first quarter of 2021 across seven investigative sites in the U.S. The SMR Stemless Reverse system has already received regulatory approval in Europe, Mexico, and certain Asia-Pacific markets, including Australia, New Zealand, and South Korea.

SMR Stemless Reverse is part of the SMR system and represents an innovative bone-preserving shoulder arthroplasty implant designed for patients with massive rotator cuff deficiencies. Its advantages include preservation of the humerus, facilitating smoother revision surgeries, and preventing complications associated with stemmed implants. According to a new market report published by Med Device Online on April 11, 2018, the use of stemless implants in shoulder arthroplasty in Europe is expected to surpass that of stemmed implants by 2025. Reports also indicate that the U.S. market shows a similar growth trend for stemless implants.

The SMR Stemless Reverse Shoulder System is compatible with the SMR Reverse Shoulder components currently approved by the FDA and marketed since 2011. The Stemless Core utilizes LimaCorporate’s leading 3D-printing technology, Trabecular Titanium (TT), along with a reverse liner on the humeral side. On the glenoid side, the polyethylene glenosphere represents an innovative solution for reverse shoulder arthroplasty, as the material inversion helps avoid scapular notching, a common complication associated with this procedure.

Luigi Ferrari, CEO of LimaCorporate, commented, “We are delighted that the IDE study for the SMR Stemless Reverse has been approved. This represents a significant and strategic milestone for LimaCorporate, enabling us to conduct clinical trials on a device designed to meet the demand for reverse shoulder arthroplasty in the U.S. market. The approval of this IDE study underscores LimaCorporate’s commitment to improving patients’ lives and empowering surgeons to help restore their patients’ passion for movement through continuous research and innovation.”

Michael Bauer, Partner at EQT and Co-Head of the EQT Healthcare team, added, “IDE approval is a significant milestone, as LimaCorporate remains committed to providing innovative solutions for surgeons while upholding high clinical standards to ensure patient safety and implant efficacy.”