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(TM) 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(TM)
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.
