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Updated 6:30 AM ET June 1, 1999
IRVINE, Calif. (BW HealthWire) - Advanced Spine Inc., a leading, worldwide
manufacturer and distributor of innovative fixation devices used in surgical
procedures of the spine, has announced the U.S. Food and Drug Administration
(FDA) has granted the company Investigational Device Exemptions (IDE)
application approval to begin clinical studies of its new cage system.
This FDA approval was made within days following the company's widely
recognized attendance and highly visible participation at the annual
American Academy of Neurological Surgeons Convention in New Orleans where
spine surgeons from all over the world were able to preview this
revolutionary new expandable cage fixation device.
The device, called VariLift(TM), has been reported to help promote the
spine's natural lordosis (natural curve of the spine) when used as a
surgical solution for degenerative disk disease. The product already has
broad market acceptance outside the United States because of its innovative,
patented design and clinical success rate.
"This positive FDA/IDE application approval permitting us to begin
investigational studies of this unique product in the United States further
substantiates our company's global commitment to maintain its leadership
position in developing, manufacturing and marketing innovative solutions to
improve spine fixation," stated William E. Maya, chairman and chief
executive officer of Advanced Spine.
With headquarters in Irvine, Calif., and European Marketing Operations
located in England, Advanced Spine manufactures and distributes a complete
line of spinal implant device systems, including VariFix(R), VariGrip(R),
VariAnchor(R) and VariLink(R).
Contact: Advanced Spine Inc., Irvine William E. Maya, 949/453-1290 or The
Sturgess Company John C. Sturgess, 949/646-3879