The FDA Orthopaedic and Rehabilitation Devices Panel has voted 9 for and 4 against (1 abstention) on safety and 10 for and 3 against (1 abstention) on effectiveness. The 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 the new bone graft option, designed for single-level, posterolateral spinal fusion procedures, were also found by a majority of those voting to outweigh any risks associated with the product by a vote of 6 for and 5 against (3 abstention).
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.
Amplify rhBMP-2 Matrix is a combination product that includes recombinant human bone morphogenetic protein-2 (rhBMP-2) solution, a synthetically produced version of a naturally occurring protein in the body, which is used to stimulate bone formation.
The Matrix also includes compression-resistant matrix (CRM), a porous carrier system, comprised of collagen and resorbable ceramic to carry the rhBMP-2 solution and maintain the rhBMP-2 at the site of implantation. The CRM also serves as a scaffold on which new bone may form.
Medtronic said that the Matrix must be used in conjunction with a metallic posterior supplemental fixation device that is indicated for temporary stabilization of the spine.
The FDA panel had reviewed data from a large, prospective clinical trial that enrolled 463 patients who were randomized to receive Amplify rhBMP-2 Matrix or undergo surgical treatment with autogenous bone harvested from their hip bone, referred to as autograft.
Amplify rhBMP-2 Matrix provides a solution for patients that lack sufficient high quality hip bone to harvest, and also eliminates the complications and pain of the bone harvest surgery in all patients.
Amplify rhBMP-2 Matrix was shown to be statistically non-inferior to autograft for the primary study endpoint, Overall Success, which was a combination of both safety and effectiveness measures. The Matrix also achieved statistically superior fusion results at 24 months, with sustained high fusion rates and patient satisfaction through 60 months.
The safety profile also compared favorably to autograft with reduced surgery blood loss and shorter mean operative times. Amplify rhBMP-2 Matrix provides a solution for patients that lack sufficient high quality hip bone to harvest, and also eliminates the complications and pain of the bone harvest surgery in all patients.
Tom McGuinness, vice president who serves as the gneral mnager of the firm’s bologics business at Medtronic, said: “Advisory Panel’s affirmative votes on all three questions represent an important first step of bringing this product to market to meet the needs of degenerative disc disease patients.
“We will continue to collaborate closely with the FDA to develop the path forward. The potential approval of Amplify rhBMP-2 Matrix will further strengthen our position as the market-leading provider of a comprehensive portfolio of bone grafting options.”