Divided FDA Panel Backs Medtronic Spine DeviceJul 29, 2010 | Parker Waichman LLP
Although federal health regulators are concerned that a new Medtronic spine-stabilizing device may increase cancer risks for some patients, the Orthopedic and Rehabilitation Devices Panel of the U.S. Food and Drug Administration's (FDA's) Medical Devices Advisory Committee just voted to endorse approval of the device, wrote MedScape.
There is one catch, however, Medtronic must conduct follow-up studies to monitor the device for adverse events including cancer and birth defects, said MedScape.
According to a prior 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 was seeking FDA approval for Amplify to stabilize vertebrae in the lower back in patients with degenerative disc disease.
The FDA panel was split on whether it should approve the device in the midst of concerns regarding RhBMP-2’s alleged links to cancer, said MedScape and The Wall Street Journal. The panel voted nine to four—one abstention—in favor of the safety and 10 to 3—one abstention—in favor of the efficacy of the Amplify recombinant human bone morphogenetic protein 2 (rhBMP2) matrix device for spinal fusion in patients with degenerative disk disease, said MedScape. When looking at risks versus benefits over the device, which is intended to form new bone, six members voted yes when asked if the benefits outweighed its risks; five voted no and three abstained, said MedScape.
Briefing documents posted to the FDA Web site earlier this month 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 to submit all studies involving use of rhBMP-2, including those conducted by another firm, Wyeth. The FDA said an analysis of the studies showed 1.7 percent of those 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 previously.
Regardless, the bulk of the panel, which included cancer experts, seemed unfazed saying the increase could be linked to the demographics—generally Medicare beneficiaries—known to experience increased cancer diagnoses, said MedScape. Most said there was "reasonable assurance" the device was safe and effective, said The Journal.
In addition to recommending if the FDA should approve Amplify, the advisory panel was also asked to comment on whether the increase in cancer cases is statistically and clinically significant, the Journal said previously. Despite that clinical studies did indicate an increase in cancer cases in patients implanted with the Amplify device, the level was not considered statistically significant, said the panel, according to The Journal.
The clinical study compared 400 patients who received the Amplify device or went through another operation to correct damaged vertebrae—taking bone from the hip for use in the spine, said The Journal.