Although two-year studies looked promising for Amplify, the five year studies are worrisome. Medtronic's spine stabilizing device has been linked to higher cancer malignancy than alternative procedures for degenerative disc disease patients. The company says the difference isn't statistically significant, but the FDA is interested enough to ask an expert panel to review the case next Tuesday.
Amplify uses a protein, rhBMP-2, to help stabilize lower vertebrae in afflicted patients. Two years after implantation, 3.8 percent of Amplify patients had cancer, compared with 0.9 percent in those receiving traditional grafts. Three years later, cancer was found in 5 percent of patients, or 13 overall, compared with the four patients receiving grafts (1.8 percent).
"The five-year data and subsequent panel discussion should naturally shed more light on the issue, but barring any new breakthrough data, we'd expect the panel to ultimately vote in favor of Medtronic," Michael Weinstein, a New York-based analyst at JPMorgan Securities, said in a July 20 report, as quoted by Bloomberg. "Amplify should ultimately win FDA approval, with the focus of next week's panel on safety and the hot button topic being cancer."
- read the FDA report
- here's the Bloomberg story
- check out Nasdaq's coverage