For Release: 7:00 am EST
on April 02, 2007
Century City Doctors Hospital Implants First Anatomic Facet Replacement
System for Spinal Stenosis Patients in the United States
LOGAN, UTAH (April 02, 2007) – Facet Solutions, Inc. announced
today that the company has completed the implantation of the
first Anatomic Facet Replacement System (AFRS™) in the
United States. The surgery was performed as part of an FDA Investigational
Device Exemption (IDE) pilot study at Century City Doctors Hospital
in Century City, California by spine surgeon, John Regan, M.D.
Facet Solutions has developed the AFRS™ as the first facet
joint replacement device anatomically designed to provide lumbar
spinal stenosis and facet degeneration patients with an alternative
to spinal fusion. The AFRS™ will potentially provide patients
with pain relief while preserving natural motion at the treated
area. It may also delay or prevent the degenerative disease process
that routinely occurs at adjacent levels after spinal fusion.
Dr. Regan, a principal investigator for the AFRS™ IDE study
said, “Spinal stenosis afflicts more than 400,000 Americans
and is the most common indication for surgery on patients over
the age of 60. With the development of new anatomically designed
total facet joint devices (AFRS™), I now have a clear alternative
for my spinal stenosis patients who may have otherwise received
a fusion.”
The results of the AFRS™ study will be submitted to the
FDA to support the approval of the device in the United States.
In Europe, the AFRS™ has already obtained a CE Mark and
is approved for use.
Century City is one of five hospitals in the U.S. involved
in this study. Qualified surgeons are continuing to look for
additional
patients with spinal stenosis who may benefit from this new
technology. For more information about the AFRS™ please call 1-866-753-1671
or visit www.facetsolutions.com.
About Facet Solutions
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.
Facet Solutions
has received venture capital from its partners De Novo Ventures,
Pequot Ventures, and Spray Venture Partners. Facet Solutions
is FDA registered and is certified to ISO 13485.
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Press Contact
Eric Olson
VP of Sales and Marketing
Facet Solutions, Inc.
435.753.1671 x-121
eolson@facetsolutions.com
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