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News

Anatomic Facet Replacement Spinal Implant System receives CE Mark approval

Facet Solutions : 21 September, 2007  (New Product)
Facet Solutions has received CE Mark Approval to market its Anatomic Facet Replacement System (AFRS)
The CE Mark enables the company’s AFRS to be marketed and distributed throughout the European Union.

The AFRS 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 USA for the AFRS.

“The CE Mark approval of our Anatomic Facet Replacement System (AFRS) 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 provides an anatomic reconstructive alternative to fusion which is sure to benefit patients who suffer from leg and back pain.”

The Facet Solutions AFRS implants are anatomically designed and utilise 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 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.


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