For release, 7:00 am Eastern Time
Monday, May 8, 2006
PRESS RELEASE
SOURCE: Facet Solutions, Inc.
Facet Solutions, Inc. Receives IDE Approval
Logan, Utah, May 8, 2006 – Facet Solutions, Inc. today
announced that the U.S. Food and Drug Administration (FDA) has
granted conditional Investigational Device Exemption (IDE) approval
for its Anatomic Facet Replacement System (AFRS™). The
approval establishes Facet Solutions as a leader in the posterior
spine motion preservation field and clears the way for a U.S.
clinical study of its AFRS™.
The AFRS™ has been developed to provide lumbar spinal
stenosis and facet degeneration patients with a motion preserving
alternative to spinal fusion. The AFRS™ utilizes precision
instrumentation and anatomic implants to reconstruct normal facet
anatomy, restoring physiological motion and stability to the
lumbar spine while allowing the surgeon to alleviate pain.
The IDE process involves an exhaustive, thorough review of all
clinical and bench top testing data by the FDA. “The rigorous
preclinical and clinical evaluation of the AFRS™ gives
us great confidence that this implant system will provide a compelling
alternative to lumbar fusion for patients in the near future,” stated
Alan Chervitz, President and CEO of Facet Solutions, Inc.
“No other motion preservation device for the posterior
lumbar spine has been designed to replicate the natural anatomy
of the facet joint,” continued Chervitz. The AFRS™ design
is based upon a detailed study of facet joint morphology. “In
other more mature segments of orthopedics such as total hip and
total knee replacement, only the designs that replicate the natural
joint anatomy have withstood the test of time,” stated
Chervitz.
Facet Solutions will begin enrolling patients into its U.S.
clinical study in the very near future. In addition to the U.S.
clinical study, the company will be conducting a clinical study
in Europe which is schedule to begin within the next two or three
months.
The Facet Solutions technology is the first anatomic facet arthroplasty
device to be developed and studied as an advanced treatment for
lumber spinal stenosis disease. Lumbar spinal stenosis is the
largest and fastest growing segment of the operative lumbar spine
market. The AFRS™ holds considerable promise as an alternative
to fusion and dynamic stabilization procedures for patients with
lumbar spinal stenosis.
ABOUT FACET SOLUTIONS, INC.
Facet Solutions, Inc. is a privately held, venture backed company
that is focused on developing and commercializing surgical
devices for the treatment of facet related spinal disorders.
The company is a MedicineLodge, Inc. spin-out company and they
will be attending the upcoming Spine Arthroplasty Society meeting
in Montreal, Canada (booth #415).
# # #
Press Contact
Alan Chervitz
President and CEO
Facet Solutions, Inc.
124 South 600 West
Logan, UT 84321
435.753.1671 x-111
alan@facetsolutions.com
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