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Facet Solutions Enrolls 100th Patient in US Pivotal IDE Study

Posted : Mon, 09 Nov 2009 21:00:17 GMT
Author : Facet Solutions, Inc.
Category : Press Release
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HOPKINTON, Mass., Nov. 9 /PRNewswire/ -- Facet Solutions, Inc. today announced that it has enrolled the 100th patient in its randomized, controlled ACADIA(TM) IDE study for lumbar spinal stenosis. "We are well ahead of our projections for 2009," stated President and CEO, Geoff Pardo. "It is indicative of the market need, the clinical outcomes that surgeons are seeing, and the ease with which they can implant ACADIA(TM)." Over 1.5 million people are diagnosed with lumbar spinal stenosis each year in the United States. Current treatment alternatives include fusion, which eliminates motion and can result in long recovery for patients.

Dr. Jim Youssef, orthopedic spine surgeon of SpineColorado in Durango, CO, remarked, "We are excited to be a part of this landmark study. Spinal stenosis is a common indication that I see in my practice, and the ability to offer patients a complete decompression while restoring motion and stability, is a very compelling proposition for both patient and surgeon."

Dr. Darryl DiRisio, neurosurgeon at Albany Medical Center in Albany, NY, added, "ACADIA(TM) is an easy to use system that has a minimal learning curve and fits into my surgical practice. What is exciting for these stenosis patients, in addition to the pain relief, is the potential for a quicker recovery over a traditional fusion."

Facet Solutions, Inc. has developed ACADIA(TM) to provide patients with lumbar spinal stenosis and facet degeneration a motion preserving alternative to lumbar spinal fusion. The ACADIA(TM) procedure includes replacement of the diseased posterior spinal joints with an anatomic implant that is designed to restore the natural motion, stability, and balance to the lumbar spine.

Dr. Antonio Castellvi will be presenting a worldwide clinical update at the upcoming North American Spine Society meeting in San Francisco, CA on November 10th at 10:15am in room 300.

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 De Novo Ventures, Pequot Ventures, and Spray Venture Partners. Facet Solutions is certified to ISO 13485. ACADIA(TM) is an investigational device in the United States. It is limited by United States (U.S.) Federal Law for investigational use only.

SOURCE Facet Solutions, Inc.


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