For Release: 7:00 am EST on September
20, 2006
Facet Solutions, Inc. Receives CE Mark Approval for the Anatomic
Facet Replacement Spinal Implant System
LOGAN, UTAH (September 20, 2006) – Facet Solutions, Inc.,
an innovator in the posterior spine motion preservation market,
announced today that the company has received CE Mark Approval
to market its Anatomic Facet Replacement System (AFRS™).
The CE Mark enables the company’s Anatomic Facet Replacement
System (AFRS™) to be marketed and distributed throughout
the European Union.
The Anatomic Facet Replacement System (AFRS™) is the first
anatomic facet arthroplasty device designed to provide patients
with lumbar spinal stenosis and facet degeneration, a motion
preserving alternative to fusion. Currently, the company is enrolling
in an FDA approved Investigational Device Exemption (IDE) clinical
study in the United States for the Anatomic Facet Replacement
System (AFRS™).
“The CE Mark approval of our Anatomic Facet Replacement
System (AFRS™) marks a significant milestone in the history
of posterior lumbar motion preservation technology,” stated
Alan Chervitz, President and CEO of Facet Solutions. “The
Facet Solutions AFRS™ provides an anatomic reconstructive
alternative to fusion which is sure to benefit patients who suffer
from leg and back pain.”
The Facet Solutions AFRS™ implants are anatomically designed
and utilize conventional pedicle screw fixation. The device is
implanted with precision instrumentation that provides reliable
and reproducible implant placement. This beneficial combination
of both anatomic design and precision instrumentation makes the
AFRS™ a compelling lumbar spine motion preservation solution
by allowing surgeons to provide patients with pain relief, while
restoring natural motion and stability at the effected lumbar
level.
*Note: AFRS™ is an investigational device in the United
States. It is limited by United States (U.S.) Federal Law for
investigational use only.
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.
Facet Solutions, Inc. is a MedicineLodge, Inc. spin-out company
and will be attending the upcoming NASS meeting in Seattle, Washington
(booth # 1620).
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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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