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Medtronic Attributes Drop in Spinal Revenue to Decline in Infuse Sales

Feb 21, 2012 | Parker Waichman LLP

A study presented this past November might be, at least partially, responsible for yet another drop in the sales of Medtronic Inc.'s Infuse bone graft product.  The company announced today that revenues from sales of its spinal products dropped 9% in the third quarter ending January 27, mostly due to a decline in Infuse sales.

Infuse sales have been on a downward track recently, not surprising when you consider the controversy that has swirled around the genetically engineered bone growth product, in recent years.  Infuse contains recombinant human Bone Morphogenetic Protein-2 (rhBMP-2), which stimulates bone growth. In 2002, Infuse was approved by the U.S. Food and Drug Administration (FDA) for use in one type of spine surgery called anterior approach lumbar fusion. Later, it was approved for use in two types of dental surgeries.

As we've reported previously, Medtronic is facing a mountain of legal trouble over Infuse, including several product liability lawsuits claiming it caused serious complications in patients In addition to lawsuits, the U.S. Justice Department, the U.S. Senate Finance Committee and the California attorney general are all investigating Medtronic's marketing of Infuse.

According to a report from the Pioneer Press, the latest slide in Infuse sales could be attributed to a study that raised more questions about the safety of rhBMP-2 late last year.  That study, presented in November at the North American Spine Society by Dr. Eugene Carragee, raised about a possible association between high doses of rhBMP-2 and an increased risk of cancer. Infuse is often administered at higher-than-approved doses when it is used in off-label procedures.

Over the summer, another article authored by Carragee and published in The Spine Journal raised serious questions about the validity of the research that was used to gain FDA approval of Infuse. The article asserted that Medtronic-paid surgeons had failed to report serious complications from Infuse that occurred during trials. An analysis conducted by Carragee and his coauthors of 13 Medtronic-funded clinical trials that ran between 2000 and 2010 found that complications, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain, occurred in 10 to 50 percent of patients who received Infuse.

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