FDA Has Concerns About Cancer Risks with New Medtronic Spine DeviceJul 26, 2010 | Parker Waichman LLP
Federal health regulators are concerned that a new Medtronic spine device may increase cancer risks for some patients. According to a Wall Street Journal report, the device, called Amplify, is made with recombinant bone morphogenetic protein-2 (rhBMP-2). RhBMP-2 is used in another Medtronic spine device known as Infuse, though that device works differently than Amplify.
Medtronic wants the US Food & Drug Administration (FDA) to approve Amplify to stabilize vertebrae in the lower back in patients with degenerative disc disease. The FDA’s Orthopaedic and Rehabilitation Devices advisory panel is set to take up Amplify tomorrow, the Journal said.
Briefing documents posted to the FDA Web site last week cited a higher number of cancer cases seen among patients in clinical trials of Amplify. The systemic effects of rhBMP-2 were a concern for the FDA, the documents said.
As part of Amplify’s application, Medtronic was asked submit all studies involving use of rhBMP-2, including those done by another firm, Wyeth. The FDA said an analysis of the studies showed 1.7 percent of patients exposed to rhBMP-2 had cancer compared to 1.3 percent of patients not exposed to the ingredient.
According to Medtronic, there were 13 cancer cases among patients who received Amplify versus four in patients who underwent a different procedure five years post-surgery, the Journal said.
In addition to recommending whether or not the FDA should approve Amplify, the advisory panel will also be asked to comment on whether the increase in cancer cases is statistically and clinically significant, the Journal said.