FDAnews
www.fdanews.com/articles/75655-medtronic-introduces-mystique-for-spinal-surgery

MEDTRONIC INTRODUCES MYSTIQUE FOR SPINAL SURGERY

August 23, 2005

Medtronic has introduced its MYSTIQUE Resorbable Graft Containment Plating System for cervical spine fusions.

The new plating system uses a high-tech biologic material that is reabsorbed by the body over time, offering spinal surgeons a feature not found in traditional metal implants, said Medtronic. When surgery is needed to alleviate nerve or spinal cord compression, a surgeon may perform an anterior cervical discectomy and fusion, where he or she makes a small incision in the front of the neck to reach the cervical spine. The disc is removed and the space is filled with bone graft. The MYSTIQUE plate is used for stabilizing the weak bony tissue around the fusion, preventing bone graft dislodgement and facilitating healing.

MYSTIQUE is made of a Hydrosorb PLDLA co-polymer, consisting of 70 percent Poly (L-lactide) and 30 percent Poly (D,L-lactide). The new plate is flexible and made of material that dissolves in the body within 18 to 36 months after implantation. The MYSTIQUE Resorbable Graft Containment Plate previously obtained FDA clearance in July 2004 for non-load bearing indications using additional rigid fixation.

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