FDA IDE approval allows a randomised, multi-centre comparative clinical trial of SMR Reverse Shoulder System in the US
LimaCorporate has secured the US Food and Drug Administration (FDA) approval for the Investigational Device Exemption (IDE) clinical trial of its SMR Stemless Reverse shoulder system in the US.
With the FDA IDE approval, the Italian medical device firm will commence a randomised, multi-centre comparative clinical trial to evaluate the safety and effectiveness of its SMR Stemless Reverse compared to the SMR Reverse Shoulder System in total reverse shoulder arthroplasty.
The clinical trial is planned to enrol 200 patients, starting from first quarter 2021, at seven US investigational sites, with a two-year follow-up.
LimaCorporate CEO Luigi Ferrari said: “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 US 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.”
SMR Stemless Reverse approved in Europe, Mexico and selected APAC markets
SMR Stemless Reverse is an advanced bone sparing shoulder arthroplasty implant intended for the treatment of patients with a grossly deficient rotator cuff.
The system offers the advantage of preserving humeral bone, and facilitates smooth revision procedures, and preventing stem-related complications.
LimaCorporate said that its SMR Stemless Reverse shoulder system is compatible with the previously approved SMR Reverse Shoulder components, available in market since 2011.
The stemless core implant features trabecular titanium (TT), the company’s 3D printed technology and a reverse liner on the humeral side.
The system has been approved in Europe, Mexico and selected APAC markets including Australia, New Zealand and South Korea.
LimaCorporate is a global medical device company offering solutions for large joint revision, primary implants and complete extremities including fixation.
EQT healthcare sector team co-head Michael Bauer said: “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.”