The FDA put the kaibosh for now on Medtronic Inc.’s (NYSE:MDT) Amplify spine device, saying it’s concerned about links between cancer and the bone morphogenetic protein it uses.
The news sent MDT shares down nearly 3 percent to $38.63 today.
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The company said the FDA "sent Medtronic a letter advising that they were not able to approve Amplify … without additional information from Medtronic," according to a quarterly filing with the federal Securities & Exchange Commission.
"We are in active dialogue with the FDA to address the issues in its letter, have been given the opportunity by the FDA to provide further information relevant to these issues, and are hopeful that the FDA will ultimately approve Amplify," according to the filing.
Asked what additional data the FDA wanted, Medtronic spokeswoman Marybeth Thorsgaard declined to comment.
"We are not going to get into the specifics of the letter. We are in active dialogue with the FDA to address the issues and have been given the opportunity to provide further information," Thorsgaard wrote in an email. "We continue to believe the case for Amplify is strong and will continue to work with the FDA to bring this important new treatment option to surgeons and their patients."
The timetable for any eventual approval rests with the federal watchdog agency, she added.
In July, an FDA advisory panel recommended that the federal watchdog agency approve the Amplify rhBMP-2 Matrix, which uses recombinant bone morphogenetic protein-2 to promote bone growth at the site of the implant. It’s designed to treat vertebral compression in the lower back in patients with degenerative disc disease. But the panel was split over the cancer risk posed by the device, voting six to five with three abstentions that the device’s benefits outweigh any risks.
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.
The rejection doesn’t bode well for Medtronic’s Infuse device, which also uses rhBMP-2 and pulled in $800 million for the company last year. The Amplify device was designed to address concerns about off-label use of the Infuse device, so its failure to win approval may augur for more scrutiny of off-label Infuse use and perhaps even reimbursement issues over covering such uses.