Facet Solutions, Inc. Expands U.S. Pivotal Study With Next Generation Implant System
HOPKINTON, Mass., April 27 /PRNewswire/ -- Facet Solutions, Inc. today announced that it has expanded its Pivotal Study to 12 sites in the United States. The ACADIA(TM) Facet Replacement Pivotal Study for the treatment of lumbar spinal stenosis utilizes the second generation design technology from Facet Solutions, Inc. This technology enables the surgeon to do a decompression and at the same time restore anatomic motion and stability to the lumbar spine. Average implantation times with the second generation design are equivalent to implantation times for standard postero-lateral fusion and dynamic stabilization.
"We are pleased to be making such rapid progress in our U.S. Pivotal Study. The enrollment rates are exceeding our enrollment targets," said Geoff Pardo, President & CEO of Facet Solutions. "The adoption of ACADIA(TM) into our surgeons' clinical practices stems from the simplicity of the surgical technique, the anatomic design, and the compelling benefits of pain relief and motion restoration for patients suffering from lumbar stenosis."
Dr. Randall Dryer, Central Texas Spine Institute, adds, "The ACADIA(TM) design takes advantage of standard pedicle screw-based fixation, and allows for predictable and precise joint restoration. My patients are seeing significant pain relief and rapid recovery as a result of this approach. This technology has the potential to significantly change how we surgically treat lumbar spinal stenosis."
Facet Solutions plans to add sites in the near future to further expand the U.S. Pivotal Study over the next three months.
The Company will be exhibiting at the upcoming Spine Arthroplasty Society (SAS) Meeting in London, England from April 27th-May 1st. Dr. Dryer will be presenting on the lumbar kinematics of the ACADIA Facet Replacement System on Thursday, April 30th at SAS.
*Note: 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.
www.facetsolutions.com
CONTACT: Mr. Geoff Pardo of Facet Solutions, Inc., +1-617-407-4865,
geoff@facetsolutions.com
Web site: http://www.facetsolutions.com/