Medtronic Infuse Controversy Opens Door for CompetitorsFeb 14, 2012 | Parker Waichman LLP
With Medtronic Inc's sales of its Infuse bone growth product taking a hit thanks to recent controversies surrounding its possible side effects, several companies could find new markets for their spinal fusion products, according to a report from MedCity News.
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. Over the summer, The Spine Journal raised serious questions about the validity of the research that was used to gain FDA approval of Infuse. In November, a prominent researcher warned that Infuse may be associated with a higher risk of developing cancer.
In addition to lawsuits, the U.S. Justice Department, the U.S. Senate Finance Committee and the California attorney general are all investigating Infuse.
One product that could benefit from Medtronic's Infuse woes is Bacterin International's OsteoSponge. In a small clinical trial, OsteoSponge did as well as Infuse in spinal fusion, without the serious risks. If those results can be duplicated in a larger study, doctors could adopt OsteoSponge as an alternative to Infuse, MedCityNews said.
Other products that could get a boost from the Infuse slump could include Osteocel Plus sold by California firm NuVasive; Trinity Evolution, sold by Orthofix Biologics in Texas; and Vitoss sold by Pennsylvania firm Orthovita, now part of Stryker.