Medtronic’s Infuse Comes Under Fire; Senate Investigates A spine product from the Spinal an

Medtronic’s Infuse Comes Under Fire; Senate Investigates

A spine product from the Spinal and Biologics division of Medtronic Inc. is drawing Capitol Hill scrutiny.
The company is under investigation for its Infuse bone graft product—recombinant human bone morphogenetic protein-2 (rhBMP-2)—approved by the U.S. Food and Drug Administration (FDA) in 2002 for spinal fusion surgery in the lower back.

The investigation was launched by the U.S. Senate Finance Committee after reports surfaced that physicians with financial ties to Medtronic failed to reveal the complications in company-sponsored research papers about clinical trials between 2000 and 2009.

The complications were published in the Journal of the American Medical Association last year and in the June issue of The Spine Journal.

Members of the Finance Committee contacted Medtronic in June and demanded an extensive list of documents, including financial records and communication between the company and the doctors who received royalties and other payments from Medtronic over the last decade. A letter signed by the committee’s chairman, Sen. Max Baucus (D-Mont.), and senior member Sen. Chuck Grassley (R-Iowa), warned Medtronic against destroying or hindering the accessibility of any documents, data or other related information.