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www.fdanews.com/articles/81283-medtronic-seeks-fda-approval-for-spinal-device

MEDTRONIC SEEKS FDA APPROVAL FOR SPINAL DEVICE

September 29, 2005

Medtronic recently submitted a premarket approval (PMA) application to the FDA for its rhBMP-2 device for posterior lumbar spinal fusion surgery.

The company based its PMA on a randomized, prospective clinical study involving more than 460 patients. The device is a bone morphogenetic protein that stimulates new bone growth or bone regeneration, and is the active component in Medtronic's Infuse Bone Graft. The FDA previously approved its use for anterior lumbar interbody fusion procedures and for certain tibial fractures.

The company says that Infuse will be the only bone graft replacement to receive PMA. More than 250,000 lumbar spinal fusions are performed each year to stabilize the vertebrae and help eliminate pain caused by degenerative disc disease in the spine