Link Spine Group Implants 5,000th Lumbar Artificial Disc
SB CHARITÉ™ Artificial Disc is designed to restore stability
and provide near-normal physiological motion as an alternative to spinal
fusion.
October 28, 2002
BRANFORD, Connecticut / October 28 / Link® Spine Group Inc., the world
leader in developing non-fusion technologies for the spine, announced
that the 5,000th SB CHARITÉ™ Artificial Disc prosthesis has
been implanted. The SB CHARITÉ™ (pronounced “sher-ee-tay”)
Artificial Disc is a total disc replacement designed to restore stability
and provide near-normal physiological motion in the lumbar spine. The
prosthesis consists of two metal endplates made of cobalt-chromium alloy
and an unconstrained sliding core made of ultra high molecular weight
polyethylene interposed between the metal endplates. These materials have
been commonly used in orthopaedic devices such as hip and knee replacements
for more than 30 years.
“This represents a significant milestone for the SB CHARITÉ™ Artificial Disc, whose clinical history now spans 15 years with the same
functional design,” said Paul Mraz, Vice President of International
Sales and Marketing for Link Spine Group. “We are very proud of
our long-term clinical history.” The SB CHARITÉ™ Artificial Disc is commercially available in 30 countries throughout Europe, Asia,
Africa and Latin America including Canada and Australia.
The SB CHARITÉ™ Artificial Disc is not available for sale in the
United States. It is currently undergoing an investigational clinical
study in the United States seeking to demonstrate safety and effectiveness.
Enrollment in the multi-center, prospective randomized study was completed
in December 2001. In the randomized study, patients received either a
disc replacement procedure or a fusion procedure and included nearly 400
patients. In early 2002, Link Spine Group began enrolling patients in
a “continued access” study on a non-randomized basis at selected
hospitals. Those patients enrolling in the “continued access”
study who meet the inclusion/exclusion criteria will receive the disc
replacement procedure only and not the fusion procedure. Hospitals involved
in the study are located in Baltimore, MD; Baton Rouge, LA; Boston, MA;
Buffalo, NY; Chicago, IL; Columbus, OH; Dallas, TX; Denver, CO; Los Angeles,
CA; Louisville, KY; Miami, FL; Nashville, TN; New York, NY and Scottsdale,
AZ.
Brian Cameron, President and CEO of Link Spine Group, said that the SB
CHARITÉ™ Artificial Disc is being investigated in the United States
as a replacement for many lumbar spine fusion procedures, currently considered
the gold standard in treating lumbar degenerative disc disease. About
200,000 lumbar spinal fusion procedures are performed each year in the
United States alone.
Link Spine Group Inc., based in Branford, Connecticut, USA, is focused
on providing breakthrough, non-fusion technologies and innovative surgical
procedures to spine surgeons for treating patients with degenerative disc
disease and related conditions of the spine. For more information, visit
Link Spine Group on the internet at www.linkspinegroup.com.
Contact: Link Spine Group Inc.
Brian Cameron, President and CEO
7 South Main Street
Branford, CT 06405 USA
(203) 315-7741
