APPROVAL AT LAST!!!
Monday September 23 8:23 AM EDT
Fda Approves Spine-Tech Bak Interbody Fusion
System Innovative Spinal Implant Treats Chronic Low
Back Pain
MINNEAPOLIS, Sept. 23 /PRNewswire/ -- Spine-Tech(R), Inc. ( Spine-Tech Inc ), announced
today that the U.S. Food and Drug Administration (FDA) has approved the Company's
BAK(TM) Interbody Fusion System, an innovative series of patented implantable devices,
proprietary instruments and surgical methods designed to treat chronic low back pain caused by
degenerative disc disease.
Spine-Tech estimates that in the United States more than 100,000 lumbar (low back) spinal
fusion procedures are performed annually to treat back pain and other spinal conditions.
Additional procedures are performed to correct failed spinal fusions. Worldwide, an estimated
200,000 lumbar spinal fusion surgical procedures are performed each year. Spine-Tech believes
that many of these spinal fusion patients are candidates for the BAK procedure.
"FDA approval opens the door to making Spine-Tech's BAK system and its medical benefits
available in the United States," said David Stassen, Spine-Tech president and chief executive
officer. "We have completed a training center at our headquarters, which will give us the capacity
to train hundreds of surgeons annually in BAK implantation surgical procedures."
The current FDA approval is for the BAK system, which is designed to stabilize and fuse
vertebrae in the lumbar (or lower) spine for treatment of chronic back pain caused by
degenerative disc disease. The Company has also initiated clinical trials for the BAK/C(R) for the
cervical (or neck region), and the BAK/T(R) for the thoracic (or chest) region.
Outside the United States, the BAK system has been approved in more than 20 nations.
An Improved Treatment Option
The BAK implants are hollow, threaded cylinders made of titanium alloy that are implanted in the
disc space between two or more vertebrae. Stabilization and fusion results from packing the
cylinders with bone graft and allowing the adjoining vertebrae to grow together through the
implant.
"In more than 1,400 procedures conducted at 20 U.S. clinical sites, the BAK system results
included low operating times and hospital stays, high fusion success rates, excellent pain relief
and reduced costs in comparison to traditional spinal fusion procedures," said John Dowdle,
M.D., Minneapolis. "In addition to offering significant improvements in the treatment of
degenerative disc disease, the BAK system may allow patients to return to work and an active
lifestyle more quickly."
Degenerative Disc Diseases: A Major Medical Expense
In the United States, back pain is the leading cause of workers' compensation expense, the
second leading reason for physician office visits, and the third leading reason for surgical
procedures. Back pain affects 12 million people, most between the ages of 20 and 60. More than
5 million Americans are disabled due to chronic back pain. The annual direct medical cost of back
pain treatment exceeds an estimated $25 billion annually and $60 million in lost worker
productivity.
Between each of the 24 vertebrae of the human spine is a vertebral disc, comprised of
cartilage-like material that separates the vertebrae and allows flexibility of movement. Injury,
aging or repeated stress can produce degenerative disc disease drying out or collapse of the disc
which can lead to excessive motion in the spine, inflammation of the nerves in and around the
spine, nerve dysfunction and severe, debilitating pain in the back, arms or legs.
The most commonly performed surgical interventions for chronic back pain are discectomies
(removal of herniated disc material) and vertebral fusions (stabilizing the spine by fusing
adjoining vertebrae).
Spine-Tech, Inc., founded in 1991 and based in Minneapolis, designs, develops, manufactures
and markets spinal implants and instruments for the surgical treatment of degenerative disc
disease and other spinal conditions. SOURCE Spine-Tech, Inc.
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Monday September 23 8:46 AM EDT
Spine-Tech Inc fusion system approved by FDA
MINNEAPOLIS, Sept 23 (Reuter) - Spine-Tech Inc said Monday the U.S. Food and Drug
Administration approved its BAK Interbody Fusion System used to treat chronic low back pain
caused by degenerative disc disease.
Spine-Tech said the system consists of a series of patented implantable devices, proprietary
instruments and surgical methods.
"FDA approval opens the door to making Spine-Tech's BAK system and its medical benefits
available in the United States," David Stassen, president and chief executive officer, said in a
statement. "We have completed a training center at our headquarters, which will give us the
capacity to train hundreds of surgeons annually in BAK implantation surgical procedures."
The current FDA approval is for the BAK system, which is designed to stabilize and fuse
vertebrae in the lumbar, or lower, spine for treatment of chronic back pain caused by
degenerative disc disease, the company said.
It added it has also initiated clinical trials for the BAK/C for the cervical, or neck region, and the
BAK/T for the thoracic, or chest, region.
Outside the United States, the BAK system has been approved in more than 20 countries,
Spine-Tech said.
Reuters Chicago Newsdesk - 312-408-8787 |
