Arthrex Releases Univers Revers™ Shoulder Arthroplasty System in the United States; First Surgery Successfully Performed in Chillicothe, OH
FOR IMMEDIATE RELEASE
Contact: Lisa Gardiner, Communications Manager
239-643-5553 ∙ Lisa.Gardiner@Arthrex.com
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.
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