For Release: 7:00 am EST
on October 22, 2007
Facet Solutions’ ACADIA™ demonstrates biomechanical
advantages over dynamic stabilization in independent testing
LOGAN, UTAH (October 22, 2007) – Facet Solutions, Inc.
announced today that testing conducted by Professor Vijay Goel,
PhD., from the Department of Bioengineering at the University
of Toledo, demonstrated that the ACADIA™ Facet Replacement System
(ACADIA™) has shown biomechanical advantages when compared
to dynamic stabilization devices. The objective of the testing
was to compare the range of motion, pedicle screw stresses, and
spinal stability of facet joint replacement versus dynamic stabilization
devices.
An experimentally validated computer model of the spine implanted
with the ACADIA™ demonstrated reduced stresses in the pedicle
screws supporting the implant. In addition, the results showed
improved motion and structural support to the spine.
“Three inherent characteristics of the ACADIA™ are
thought to contribute to these positive results,” stated
Professor Goel. “These characteristics are: the anatomic
implant design, the unconstrained range of motion, and the replacement
of diseased bone with a cobalt chrome implant. Additional testing
will be conducted to determine the impact that the ACADIA™ will
have on disc pressures when implanted in the spine.”
When treating patients with low back pain, one of the most important
concerns for a spine surgeon is how to stabilize the spine after
performing a spinal decompression (removal of bone around inflamed
nerve roots). In the past, the only option available was a spinal
fusion. However, a fusion eliminates motion and may cause the
joints adjacent to the fusion to degenerate more quickly. These
concerns lead to the development of motion preservation devices
like dynamic stabilization and facet joint replacement. Dynamic
stabilization is an adjunct to fusion and typically utilizes
preloaded rods and screws to provide controlled motion. By contrast,
facet joint replacement allows for unconstrained motion and mimics
the natural kinematics, balance, and stability in the spine joints;
similar to hip and knee joint replacement devices.
Recent studies have shown that the constrained nature of dynamic
stabilization increases screw stresses. This increase may have
contributed to the higher rates of screw loosening and resulted
in limited range of motion. The objective of the biomechanical
testing was to determine if the use of an unconstrained implant
could potentially eliminate the disadvantages of dynamic stabilization.
Eric Bannon, VP of Clinical and Regulatory Affairs, stated, "The
ACADIA™ was designed with the objective of overcoming the
inherent weaknesses of spinal fusion and dynamic stabilization.
As a company, we felt it was important to invest in this stringent
testing procedure to ensure that the ACADIA™ would result
in positive clinical outcomes. We were pleased to find that our
product outperformed spinal fusion and dynamic stabilization
in several key areas. The company looks forward to expanding
this biomechanical outcome data with results from an ongoing
FDA approved IDE Study.”
The summary findings from this biomechanical testing will be
presented at the Science of Facet Joint Repair and Total Posterior
Arthroplasty Symposium which will be held in Austin, Texas at
the Omni Hotel on Monday, October 22, 2007 at 6:30 PM.
*Note: ACADIA™ 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.
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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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