Healthcare Industry News:  degenerative disc disease 

Devices Orthopaedic Neurosurgery

 News Release - January 17, 2008

Spinal Elements(TM) Announces Successful Completion of Landmark Spine Surgery

Zyre(TM) Facet Implant System Provides a Minimally-Invasive, Motion-Preserving Option for Patients with Chronic Back Pain

CARLSBAD, Calif.--(HSMN NewsFeed)--Spinal Elements announced today that the first implantation of their highly-anticipated Zyre Facet Implant System in December 2007 was a success. It is the first arthroplasty system developed specifically to address facet joint pain.

Pioneer spine surgeon Rudolf Bertagnoli, M.D. performed the minimally-invasive, tissue-sparing procedure, which directly addresses the small facet joints present in every level of the spine. Top surgeons, Carl Lauryssen, M.D., of Tower Orthopedics in Beverly Hills, CA and Scott Kitchel, M.D., of Orthopedic Spine Associates in Eugene, Oregon, assisted in the procedure. It is the first of a set of surgeries being performed in Germany to evaluate the Zyre system performance.

“This procedure represents a breakthrough in the treatment of chronic back pain,” said Dr. Bertagnoli. “The technology provides a large population of patients living with chronic facet pain with an alternative to fusion or reliance on perpetual conservative treatments such as injections and manipulation.”

More than 50 percent of patients with chronic back pain exhibit some or most of that pain in the facet joints. A recently approved procedure called Total Disc Replacement (TDR) addresses degenerative disc disease (DDD), but fails to treat degenerative facet joints, which usually contribute to back pain in patients with DDD. Recent studies of patients who underwent TDR surgery indicate that over 50 percent of patients have progression of facet joint disease two years following the TDR procedure. Additionally, symptomatic facet joints are the leading contraindication for TDR present in 91 percent of patients requesting TDR but later undergoing other spinal procedures.

Currently, DePuy Spine, Inc., a unit of Johnson and Johnson, Synthes Inc., and Medtronic Sofamor Danek, Inc. have FDA-approved TDR products, but few companies have taken the next step into facet joint arthroplasty. Spinal Elements™ has distinguished itself by providing a procedure to augment the facet joints instead of removing them. Spinal Elements believes the market potential for its Zyre™ Facet Implant System may approach one billion dollars annually.

“We are very encouraged by this first procedure and believe there is a vast opportunity for the application of this technology,” commented Jason Blain, Chief Technology Officer for the Spinal Elements. “We believe the Zyre system will offer a host of patients surgical options in the future that simply are not available today.”

About Spinal Elements, Inc.

Spinal Elements Inc., headquartered in Carlsbad, California, is a spine technology company with unique spinal implant technologies that are marketed throughout the US. Spinal Elements is focused on developing innovative fusion and spine motion preservation technologies. Spinal Elements currently markets a full line of commercially successful spinal implants. The worldwide spine market is valued at over $5 billion and growing at a rate greater than 20 percent annually. Chronic back pain is the largest cause for missed work and among the most frequent reason patients visit physicians. Zyre is an investigational device and is not currently available in the United States.

Additional information is available on the company website at www.spinalelements.com.

Further inquires may be sent to zyre@spinalelements.com.


Source: Spinal Elements

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