Medtronic Spinal Fusion Device Faces US FDA Review

A standard spinal-fusion procedure requires two surgeries, often done at the same time, Martin Yahiro, Medtronic’s senior director of clinical and regulatory affairs, said in a July 21 telephone interview. First, doctors operate to take a section of hip bone for use as a graft for the second procedure that repairs the spine, he said.

Amplify combines the company’s bone growth protein, known as rhBMP-2, with a ceramic device implanted in the spine for posterior spinal fusion through the patient’s lower back. The bone protein, marketed as Infuse, won U.S. approval in 2002 for anterior fusion surgeries, a lower-back operation performed through an incision in the front of the patient. It is also cleared for dental procedures and to repair lower leg fractures. Infuse generates as much as $800 million in annual revenue for Medtronic, with sales unchanged the past two years, Weinstein said.

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