The recent controversy surrounding Medtronic Inc.’s Infuse bone graft could help other products gain a foothold in the lucrative spinal fusion market. According to from MedCityNews, while no product currently available could completely replace Infuse, there are a few that could come to be considered a next-best option
First approved by the U.S. Food and Drug Administration (FDA) in 2002, Infuse has been cleared for use in a type of spine surgery called anterior approach lumbar fusion, as well as two types of dental procedures. However, recent research has shown that Infuse, also known as recombinant human Bone Morphogenetic Protein-2 or BMP2, may increase the risk that patients will develop cancer and other serious side effects Concerns have also been raised about the Medtronic-funded clinical trials used to gain approval of Infuse, with some researchers charging that the studies downplayed serious complications associated with the bone growth protein. Medtronic has also faced investigations launched by the U.S. Justice Department and the U.S. Senate Finance Committee over possible illegal promotion of Infuse for off-label uses, as well as a growing number of personal injury lawsuits filed by victims of alleged Infuse complications.
These controversies have caused Infuse sales to decline, as doctors began limiting its use or abandoning it altogether. In an effort to salvage the reputation of Infuse, Medtronic has commissioned Yale University to oversee two independent, systematic reviews of all Infuse-related clinical data, the results of which are expected to be concluded in the next fiscal year. But many experts believe that, regardless of the results of the Yale review, the hit to Infuse sales is probably permanent.
According to MedCityNews, there are a number of products on the market that could step in to fill the void created by the Infuse controversies. These 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.
One product, called OsteoSponge, appears to be particularly promising, according to an analyst interviewed by MedCityNews. Made by Bacterin International, OsteoSponge performed well against Infuse in a small, head-to-head clinical trial. Not only did it perform as well as Infuse with none of the risks connected to the Medtronic product, OsteoSponge costs about 1/3 less. Caroline Corner, the analyst from MLV & Co., told MedCityNews that if OsteoSponge can do as well in a larger clinical trial, it could gain some of Infuse’s market share.