Resorbable Implant For Spinal Surgery Introduced

Minneapolis - Medtronic, Inc. announced the market introduction of the MYSTIQUE Resorbable Graft Containment Plating System for cervical spine fusions. This 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.

The MYSTIQUE Plate is the first implant of its kind for spinal surgery. When surgery is needed to alleviate nerve or spinal cord compression, a surgeon may perform a procedure called an anterior cervical discectomy and fusion. In this procedure the surgeon 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. The new plate is flexible and made of material that dissolves in the body within 18 to 36 months after implantation.

Nearly 200,000 cervical spinal fusions are performed each year to treat degenerative disc disease. Degenerative disc disease, which affects approximately half of the population age 40 and older, can cause a variety of symptoms, including back or neck pain, nerve root pathology and spinal cord compression. Spinal fusion, a surgery commonly used to treat degenerative disc disease after conservative treatments have failed, stabilizes the vertebrae to eliminate the pain caused by a degenerated disc.

The plate's transparent nature allows doctors to visualize the spine during surgery and can improve the reading of postoperative X-rays. The plate can also be contoured to better match the patient's unique anatomy before insertion.

The MYSTIQUE Plate is made of HYDROSORB(R) PLDLA co-polymer. This co-polymer consists of 70 percent Poly (L-lactide) and 30 percent Poly (D,L-lactide). More than 10 years of clinical experience and research have shown that implants manufactured from PLDLA materials provide clinicians with a higher level of surgical versatility.

"The MYSTIQUE Plate could bring a new approach to spine surgery," said Peter Wehrly, vice president and president of Spinal and Navigation for Medtronic. "This device works like resorbable sutures. Once the bones fuse, the plate dissolves leaving the patient without a permanent implant in their neck."

"The MYSTIQUE Plate is a valuable new tool for spine surgeons when it comes to cervical fusion," said Brent Morgan, M.D., of the North Texas Neurosurgical Associates in Richardson, Texas. "It enhances the abilities of spinal surgeons treating degenerative cervical spine disease and nicely compliments current titanium implants."

The MYSTIQUE Resorbable Graft Containment Plate received U.S. Food and Drug Administration clearance in July 2004, for non-load bearing indications using additional rigid fixation.

SOURCE: Medtronic