For Release: 7:00 am EST on April
23, 2009
Facet Solutions Completes 1 Year Follow-up on US Pilot Study
Hopkinton, MA (April 22, 2009) – Facet Solutions, Inc.
today announced the publication of its one-year data for the
ACADIATM US Pilot Clinical Study. The study utilized the ACADIATM
Facet Replacement System for the treatment of lumbar spinal stenosis.
The results showed dramatic improvements across all measures,
including an 88% reduction in Oswestry Disability Index, a 77%
reduction in back pain, and an 83% reduction in leg pain. There
were no device-related adverse events in any of the patients.
“
The results continue to be impressive,” commented Dr. John
Regan (St. John’s Hospital, Santa Monica, CA), who is the
principal investigator for the ACADIATM stenosis study. “”Facet
replacement surgery will offer stenosis patients who currently
undergo lumbar fusion a compelling motion preservation option
to address both pain and function.”
Facet Solutions’ President & CEO Geoff Pardo added, ”These
results have exceeded our expectations and provide us with further
confidence that this important technology will provide significant
patient benefits. Patients and surgeons tell us they want a lumbar
spine solution which provides pain relief and anatomic motion,
and we think we have that solution.” Facet Solutions, Inc.
is currently enrolling patients in its Multi-center Pivotal Study
in the United States.
One year data from Facet Solutions’ US Pilot Study will
be presented at the upcoming Spine Arthroplasty Society meeting
(SAS9) to be held April 27th-May 1st, 2009 in London, England.
*Note: ACADIATM 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
focused on development and commercialization of surgical devices
for the treatment of facet-related spinal disorders. Facet Solutions
has received venture capital from its partners DeNovo Ventures,
FirstMark Capital, and Spray Venture Partners. Facet Solutions
is FDA registered and is certified to ISO 13485.
# # # Press Contact
Mr. Geoff Pardo
President & CEO
Facet Solutions, Inc.
45 South Street
Hopkinton, MA 01748
617-407-4865
geoff@facetsolutions.com
www.facetsolutions.com
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