The U.S. Food and Drug Administration (FDA) Orthopaedic and Rehabilitation Devices Panel today voted 9 for and 4 against (1 abstention) on safety and 10 for and 3 against (1 abstention) on effectiveness, that data including results from a large, prospective randomized clinical trial demonstrated the safety and effectiveness of AMPLIFY™ rhBMP-2 Matrix for fusions of the lower spine in patients with degenerative disc disease. The benefits of this new bone graft option, which is specifically designed for single-level, posterolateral spinal fusion procedures, were also found by a majority of those voting to outweigh any risks associated with this product by a vote of 6 for and 5 against (3 abstention).
“AMPLIFY™ rhBMP-2 Matrix represents a monumental advancement in the arsenal of bone grafting options available for posterolateral spine fusions. This is the first recombinant bone graft that has been proven to yield statistically higher fusion rates than the current standard of care”
AMPLIFY™ rhBMP-2 Matrix was found in the clinical trial to produce statistically higher rates of bone fusion at the designated 24-month endpoint compared to the control group, which used the patient's own bone harvested from the hip. Harvested hip bone, long considered the standard of care bone graft, presents challenges for patients and surgeons, including the need for a second surgery to harvest the bone.
"AMPLIFY™ rhBMP-2 Matrix represents a monumental advancement in the arsenal of bone grafting options available for posterolateral spine fusions. This is the first recombinant bone graft that has been proven to yield statistically higher fusion rates than the current standard of care," said James Hardacker, MD, an orthopedic surgeon from Indianapolis, and a researcher in the AMPLIFY™ rhBMP-2 Matrix clinical trial. "With this important new product, a second operation to harvest bone from the hip, which can increase pain and other complications for the patient, can be avoided."
AMPLIFY™ rhBMP-2 Matrix is a combination product that includes the following: