The FDA has rejected Medtronic's ($MDT) Amplify, a spine device that was linked to higher cancer malignancy than alternative procedures for degenerative disc disease patients. The company had maintained the difference isn't statistically significant, but the FDA apparently still had concerns.
Amplify uses a protein called rhBMP-2 to help stabilize lower vertebrae in patients. But in tests, 3.8 percent of Amplify patients had cancer two years after implantation, compared with 0.9 percent in those receiving traditional grafts. Three years later, cancer was found in 5 percent of patients--13 overall--compared with the four patients receiving grafts, or 1.8 percent.
In a regulatory filing, Medtronic disclosed the FDA sent a letter in Q3 of fiscal 2011 saying it wasn't able to approve the product without additional information. The company says it will continue to seek approval to market Amplify and adds it is "in active dialogue" with the agency to address the problems mentioned in the letter.
Last summer, an expert FDA panel cast a narrow vote on Amplify. Although six members said the benefits of the device outweigh the risks, five said no and three abstained. Many panelists wanted more data, with some saying they didn't know whether it made a difference in patients. During the meeting, panelists kept coming back to the cancer question, and ensuring patient safety came up numerous times, with one panel member asking, "Is this something you want to put in Aunt Millie?"
As MarketWatch notes, the rejection raises questions about another already marketed Medtronic spine product that uses the same ingredient and contributed $800 million in sales last year. Medtronic shares fell 2.3 percent in midday trading Thursday on the New York Stock Exchange.
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