FDA looks at Medtronic's Amplify's potential cancer risks

by Heather Mayer, DOTmed News Reporter | July 27, 2010

The company will work
with the FDA.

The U.S. Food and Drug Administration is taking a closer look at Medtronic Inc.'s Amplify spinal implant, not yet on the market, which uses a bone morphogenic protein to stimulate bone growth, after reports suggest an elevated risk of cancer.

The FDA's Orthopaedic and Rehabilitation Devices panel will review the implant today to determine whether the increased cancer cases in patients treated with the device will require further investigation.

The FDA has turned the case over to its panel for several reasons, including that the implant is the first combination product that uses recombinant bone morphogenetic protein-2 to promote bone growth, and the number of cancer cases reported in the clinical study in patients treated with the device is higher than patients who were treated with the control device.

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Some of the cancers in the experimental group included lung, ovarian, pancreas and prostate cancers, while the cancers in the control group included non-Hodgkin's lymphoma, colon cancer, thyroid and squamous cell carcinoma.

Of the patients in the experimental group, nine, or 3.8 percent, developed cancer over a two-year span, compared with two, or 0.9 percent in the control group. And over a five-year span, there were 13 cancer events in 12 patients in the experimental group, or 5 percent, compared with four cases in four patients, or 1.8 percent, in the control group.

The company will present pre-clinical and clinical data to the panel, along with an expert opinion that "no plausible biological mechanism for cancer induction or promotion has been identified, and that observed cancer rates are not statistically different between patients who received the Amplify treatment or other [similar] products and patients who did not receive [them]," said company spokesman Brian Henry in prepared remarks e-mailed to DOTmed News.

The FDA also wants to look at the potential risks to women's reproductive health.

"Medtronic and FDA will continue to discuss possible study designs to monitor long-term safety, post-commercialization," said Henry.