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FDA sends non-approval letter for Medtronic’s new rhBMP-2 product
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In a recent quarterly report to the United States Securities and Exchange Commission, Medtronic, Inc. noted that it received a letter from the FDA stating that th agency could not approve the company’s AMPLIFY recombinant human bone morphogenetic protein-2 Matrix without more information.
The new bone graft product is intended for patients with degenerative disc disease undergoing single-level, posterolateral spinal fusion.
“We are in active dialogue with the FDA to address the issues in its letter, have been given the opportunity by the FDA to provide further information relevant to these issues, and are hopeful that the FDA will ultimately approve Amplify,” Medtronic wrote in its 10-Q form.
As reported in Orthopedics Today last July, the FDA Orthopaedic and Rehabilitation Devices panel voted in favor of the product gaining pre-market approval. The 14-member panel voted 9-4 with one abstention that the device was safe and 10-3 with one abstention that it was effective. They also voted 6-5 that the benefits of the product outweighed its risks with three panelists abstaining from that vote. Panelists at the time noted unclear indications and insufficient data regarding dose dependency and heterotopic ossification with the product.
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