PR86723

UDINE, Italy, Nov. 20, 2020 /PRNewswire=KYODO JBN/ --

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.

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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."

About LimaCorporate

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.

For additional information on the Company, please visit:

http://limacorporate.com 

Limacorporate S.p.A.

Via Nazionale, 52

33038 Villanova di San Daniele del Friuli

Udine - Italy

T: +39 0432 945511

E: info@limacorporate.com

SOURCE: Limacorporate S.p.A.

CONTACT: stefania.antonutti@limacorporate.com (+39 366 6163444),

elena.feresin@limacorporate.com (+39 377 529 2473)