Thermoplastic Vertebral Body Replacement

It has been cleared by the U.S. Food and Drug Administration (FDA).

The Graftcage ACX, developed by Osteotech (Eatontown, NJ, USA), is manufactured from polyetheretherketone (PEEK), a polymer that is an exceptionally strong engineering thermoplastic. Implantable-grade PEEK polymer is characterized by its biocompatibility and its biostability.

The GraftCage is intended to restore the height of a collapsed vertebral body, and is intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine. It is indicated for a partial or total vertebrectomy in cases of tumor or trauma-related damage to the vertebral body.

The GraftCage features titanium markers to facilitate intra-operative and post-operative radiographic assessments and an opening for the insertion of bone grafting materials, including a new form of the recently introduced Xpanse bone insert, also from Osteotech, to allow for maximum graft exposure.

This new version of the Xpanse bone insert is expected to be launched concurrently with the launch of the GraftCage. Used together, they create a vertebral body spacer allowing for maximum end-plate contact, structural support, osteoinductivity and osteoconductivity, the four key functional requirements for a successful fusion.

"The GraftCage ACX is the first in a series of new products from Osteotech manufactured from PEEK,” said Sam Owusu-Akyaw, president and chief operating officer of Osteotech. The company expects to introduce more PEEK products into the overall spinal interbody market over the course of 2006.




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