Arthrex Releases Univers Revers™ Shoulder Arthroplasty System in the United States; First Surgery Successfully Performed in Chillicothe, OH
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Contact: Lisa Gardiner, Communications Manager
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Arthrex Releases Univers Revers™ Shoulder Arthroplasty System in the United States
First Surgery Successfully Performed in Chillicothe, OH
NAPLES, FL – June 14, 2013 – Arthrex has released its innovative Univers Revers Shoulder Arthroplasty System in the United States, and the first surgery was successfully performed this week by Brian S. Cohen, M.D. in Chillicothe, OH. This is following clearance of the system by the U.S. Food and Drug Administration on May 31, 2013.
“The recent FDA clearance of the Arthrex Univers Revers Shoulder Arthroplasty System is another testimony to Arthrex’s continuous innovation in helping surgeons treat their patients better,” said Reinhold Schmieding, Arthrex President and Founder. “We applaud our creative engineers, tenacious regulatory affairs management and dedicated consulting surgeons worldwide for this significant achievement in orthopaedic surgery.”
A reverse shoulder replacement is a beneficial option for patients with large rotator cuff tears who have developed a complex type of shoulder arthritis called “cuff tear arthropathy.” In a conventional total shoulder replacement, which is commonly performed to treat shoulder arthritis, the implant device replicates the normal anatomy of the shoulder. (A plastic “cup” is fitted into the shoulder socket – or glenoid – and a metal ball is attached to the top of the upper arm bone – or humerus.) However, in a reverse shoulder replacement, the socket and metal ball are switched. The metal ball is fixed to the socket and the plastic cup is fixed to the upper end of the humerus.
A reverse shoulder replacement may result in less pain and improved range of motion for people with cuff tear arthropathy because it relies on different muscles to move the arm. In a healthy shoulder, the rotator cuff muscles help position and power the arm during range of motion. A conventional total shoulder replacement device also uses the rotator cuff muscles to function properly. However, in a patient with a large, irreparable rotator cuff tear and cuff tear arthropathy, these muscles no longer function. The reverse shoulder replacement relies on the deltoid muscle, instead of the rotator cuff, to power and position the arm.
Reverse shoulder replacement surgery was introduced in the United States in 2004. However, Arthrex’s newly-released system incorporates unique and clinically appropriate features that further advance arthroplasty implant technology. According to Dr. Cohen, “The Arthrex Univers Revers Shoulder Arthroplasty System offers important clinical options such as a variable neck angle of 135 degrees and 155 degrees and a humeral press-fit component, which have not been previously available to surgeons in one system on the market today.”
The variable neck angle allows the surgeon to match the patient’s clinically-specific issues with an appropriate humeral reconstruction. (In certain clinical situations, the 135 degree angle may allow patients more motion, while the 155 degree angle may provide more stability.) In addition, the humeral press-fit component allows the patient’s bone to heal to the component and gives it a stronger, longer lasting bond over time.
“The Arthrex Univers Revers Shoulder Arthroplasty System was designed to address both the routine and complex conditions of the rotator cuff deficient shoulder, said Anthony Romeo, M.D., a sports medicine, elbow and shoulder orthopaedic surgeon in Chicago, IL and a lead member of the Univers Revers design team. “The innovative design and multiple options for reconstruction were developed after careful consideration of the many issues faced by surgeons in treating these patients. Every effort was made to make the system ‘surgeon-friendly’ and intuitive, improving our ability to help our patients achieve successful outcomes.”
Arthrex’s Univers Revers Shoulder Arthroplasty System has been utilized in Europe since 2012, with over 500 prostheses implanted to date.
Arthrex, headquartered in Naples, FL, is a global leader in orthopaedic product development and medical education for orthopaedic surgeons. More than 7,500 products for arthroscopic and minimally invasive orthopaedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.Arthrex.com.