Facet Solutions Completes 1 Year Follow Up On U.S. Pilot Study

Main Category: Neurology / Neuroscience
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 24 Apr 2009 - 4:00 PDT

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Facet Solutions, Inc. announced the publication of its one-year data for the ACADIA(TM) U.S. Pilot Clinical Study. The study utilized the ACADIA(TM) 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 ACADIA(TM) 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' U.S. Pilot Study will be presented at the upcoming Spine Arthroplasty Society meeting (SAS9) to be held April 27th-May 1st, 2009 in London, England.

ACADIA(TM) 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.

Source: Facet Solutions

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