CHICAGO, April 13, 2011 /PRNewswire/ — Medyssey Co., Ltd., the
parent company of Medyssey Spine, a spinal
implant manufacturer focused on commercializing products for the
surgical treatment of spine disorders, today announced that the
Company has received 510(k) clearance from the FDA for its LP
Cage™ indicated for use in skeletally mature patients with
Degenerative Disc Disease at one or two contiguous levels from
L2-S1 from a posterior approach for lumbar interbody fusion. The
product is currently in limited, controlled release and is targeted
for full commercial launch by Q4 2011.
According to Frost & Sullivan, more than 30 million people
in the United States suffer from back pain. While physical therapy
and medication provide a solution in many cases, a subset of
approximately 15 percent, about 4.5 million people, still
experience chronic back pain requiring the next level of treatment
which is spinal surgery, involving spinal fusion, or in some cases,
total disc replacement.
Medyssey Spine’s LP Cage™ device addresses the market need
for advanced spinal fusion solutions with an indication comprised
of two footprints with three varying degrees of lordosis and
substantial graft windows for maximum endplate to endplate contact.
“Given the challenging regulatory climate, we are extremely
pleased to obtain clearance, and we are eager to introduce, market,
and sell the first of many cages of what will ultimately be an
extensive portfolio of interbody fusion systems,” said Joseph Jin,
the Company’s vice president of sales for the Americas. “Medyssey’s
focus is to have the most complete thoracolumbar
systems on the market, which is evidenced by our robust pipeline of
new products currently in regulatory submission and commitment to
building out our interbody and biologics platforms,” Mr. Jin
added.
In addition
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