Country for PR: United Kingdom
Contributor: PR Newswire Europe
Friday, November 20 2020 - 02:00
LimaCorporate Announces FDA Approval for an Ide Study on Smr Stemless Reverse Shoulder System
UDINE, Italy, Nov. 20, 2020 /PRNewswire-AsiaNet/ --

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:

Limacorporate S.p.A. 
Via Nazionale, 52 
33038 Villanova di San Daniele del Friuli 
Udine - Italy 
T: +39 0432 945511 

SOURCE: Limacorporate S.p.A.

CONTACT: (+39 366 6163444), (+39 377 529 2473)