PR89070

SAN DANIELE DEL FRIULI, Italy, April 20, 2021, /PRNewswire=KYODO JBN/--

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."

About LimaCorporate

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

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press@limacorporate.com  

info@limacorporate.com  

+39 0432 945511

SOURCE: Limacorporate S.p.A.