LOGAN, Utah, Sept. 20 /PRNewswire/ -- Facet Solutions, Inc., an innovator in the posterior spine motion preservation market, announced today that the company has received CE Mark Approval to market its Anatomic Facet Replacement System (AFRS(TM)). The CE Mark enables the company’s Anatomic Facet Replacement System (AFRS(TM)) to be marketed and distributed throughout the European Union.
The Anatomic Facet Replacement System (AFRS(TM)) is the first anatomic facet arthroplasty device designed to provide patients with lumbar spinal stenosis and facet degeneration, a motion preserving alternative to fusion. Currently, the company is enrolling in an FDA approved Investigational Device Exemption (IDE) clinical study in the United States for the Anatomic Facet Replacement System (AFRS(TM)).
“The CE Mark approval of our Anatomic Facet Replacement System (AFRS(TM)) marks a significant milestone in the history of posterior lumbar motion preservation technology,” stated Alan Chervitz, President and CEO of Facet Solutions. “The Facet Solutions AFRS(TM) provides an anatomic reconstructive alternative to fusion which is sure to benefit patients who suffer from leg and back pain.”
The Facet Solutions AFRS(TM) implants are anatomically designed and utilize conventional pedicle screw fixation. The device is implanted with precision instrumentation that provides reliable and reproducible implant placement. This beneficial combination of both anatomic design and precision instrumentation makes the AFRS(TM) a compelling lumbar spine motion preservation solution by allowing surgeons to provide patients with pain relief, while restoring natural motion and stability at the effected lumbar level.
*Note: AFRS(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 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.
Facet Solutions, Inc. is a MedicineLodge, Inc. spin-out company and will be attending the upcoming NASS meeting in Seattle, Washington (booth # 1620).
Source: Facet Solutions, Inc.
