Medyssey Spine Receives 510(k) Clearance for Its LP Cage(TM) Posterior Lumbar Interbody Fusion System
Published: Apr 14, 2011
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, the Company also announced a record 84 percent increase in U.S. sales in Q1 2011 over Q1 2010, and is on pace to achieve its eighth consecutive year of market share growth in the global spine market. Medyssey's booth number is 942 at the American Association of Neurological Surgeons (AANS) - 2011 Annual Scientific Meeting held this week, April 9-13, at the Colorado Convention Center in Denver, Colorado.
About Medyssey Spine
Privately owned and headquartered in Seoul, Korea, Medyssey is the second largest spinal implant manufacturer in South Korea. Founded in 2003 by Edward J.W. Jang, the Company has a pioneering focus on bringing leading orthopedic and neurosurgical spinal implants to market. Medyssey designs, develops, manufactures, and markets products for the surgical treatment of spine disorders through novel implants, instrumentation and orthobiologics solutions aimed at improving spinal fusion rates, preservation of mobility and clinical outcomes.
Todd E. Appleman
The Appleman Group
SOURCE Medyssey Co., Ltd.