Despite its concerns over possible cancer risks associated with Medtronic Inc.’s (NYSE:MDT) Amplify spinal implant, a Food & Drug Administration advisory panel recommended that the federal watchdog agency approve the device.
The FDA’s Orthopaedic and Rehabilitation Devices panel wanted more information on whether the higher number of cancer cases among patients treated with the Fridley, Minn.-based medical device monolith’s device warrant further investigation. The device uses recombinant bone morphogenetic protein-2 to promote bone growth at the site of the implant, which is designed to treat vertebral compression in the lower back in patients with degenerative disc disease.
Of the patients implanted with the device in clinical studies, nine developed cancer over a two-year span (3.8 percent of that group), compared with two, or 0.9 percent, in the control group, according to the FDA (PDF). Over a five-year span, there were 13 cancer events in 12 patients in the Amplify group (5 percent), compared with four cases in four patients (1.8 percent) in the control group. Two more Amplify cancer events were reported in Medtronic’s 2010 annual report for its investigational device exemption, with one more in the control group, bringing the total number of cancer events to 15 for 12 Amplify patients and five events for five of the control group patients.
Although none of the cancer events was classified as related to the device, the FDA wants the panel to “discuss the clinical significance of the results of these evaluations of the reported cancer events, and discuss whether any additional evaluations or analyses are necessary,” according to the agency.
After its review, the panel recommended approval of the device, voting nine to four with one abstention on safety; 10 to three with one abstention on effectiveness; and six to five with three abstentions that the device’s benefits outweigh any risks, according to a Medtronic press release.
It’s obviously good news for Medtronic and at least one analyst thinks it could be good news for the company’s investors. Rick Wise of Leerink Swann, in a note to investors, wrote that his firm is "encouraged" by the panel’s vote and remains "cautiously optimistic" that the device will win FDA approval in the next six to 12 months and has the potential "to drive increased sales momentum for MDT’s under-performing spine business.”
"Our recently published survey of 71 higher volume US spine surgeons suggests that Amplify — if approved — has the potential to drive: 1) incremental rhBMP-2 use, 2) higher spine procedure volumes, and 3) higher MDT spine sales," Wise wrote. "Clearly, our assumptions on Amplify’s pricing, spine industry growth, and initial adoption trends are ‘best guesses.’ Still, we estimate Amplify could add $130M-$175M and $0.05-$0.08/shr to MDT’s annual (CY) sales/EPS in the first 12 months post-approval.”