November 25, 2008
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Medtronic receives subpoena concerning off-label use of spinal graft

The U.S. Department of Justice (DOJ) has sent a subpoena to Medtronic Inc. as part of an investigation into ongoing off-label uses of its Infuse spinal graft.

Bill Hawkins, chief executive for Medtronic, discussed the subpoena during a conference call with investors and analysts.

“For years, Medtronic has had strict guidelines in place on appropriate promotion of products according to labeled indications,” Hawkins said in a press release. “We are complying appropriately with the DOJ’s request.”

The FDA investigation is focused on Infuse (recombinant human bone morphogenetic protein-2, or rhBMP-2). Hawkins also said he wasn’t surprised that Medtronic received the subpoena in light of “stepped-up efforts in general ... on the topic of off-label use of drugs and devices," according to the press release.

He said his company takes the concept of appropriate promotion for on-label use “very seriously.”

This summer, Medtronic officials stated in press releases that the company does not pay surgeons to promote Infuse for unapproved uses.

The FDA approved the graft for use in lumbar fusion with a cage, as well as for tibial fracture repair and certain oral and dental procedures. However, in July, the FDA reported there were several reports of complications associated with the use of Infuse to repair the cervical spine.

In April, Medtronic announced it received FDA approval to market two smaller kit sizes of Infuse for use in certain spinal fusion and dental regenerative procedures. At that time, Doug King, vice president of sales for Medtronic’s spinal and biologics business, said in a press release that Infuse has been used successfully in treating more than 500,000 patients since its introduction to market.