Article preview from IN VIVO - November, 2011
Medtronic's INFUSE bone morphogenetic protein is the only product in the musculoskeletal industry that has changed the bar in terms of bone healing, and it is under fire for complications related to off-label use. As regulators and payors crack down on INFUSE and hospitals restrict access to the product, surgeons are seeking alternatives and there are a number of companies lining up to fill the void.
Article preview from IN VIVO - November, 2011
The medical technology arena is home to a number of “game-changing” technologies that initially took the industry by storm only to see their meteoric rise followed by a precipitous fall. The drug-eluting stent market is one example marked by an evolutionary (indeed some would say revolutionary) technology that was widely and broadly adopted for the first few years following market introduction, but took a hit when concerns surfaced about off-label use and potential complications. Even though those concerns were largely ameliorated, the market never did return to its initial fervor. More recently, studies suggesting implantable cardioverter defibrillators (ICDs) are often used outside of recommended guidelines and have thrown the cardiac rhythm management arena into a quandary as well. And now, a similar but potentially even more serious story is playing out in the musculoskeletal industry.
Only one product in the musculoskeletal arena has changed the bar in terms of bone healing and that is INFUSE, Medtronic Inc.’s blockbuster bone morphogenetic protein (BMP), which accounts for 40% of the $1.74 billion market for bone replacement materials. Now, however, INFUSE is being slammed by a backlash from professional societies, and the inevitable emergence of class action lawsuits. Safety issues originating from the use of INFUSE in the cervical spine mushroomed into allegations of off-label promotion, triggering a Department of Justice (DOJ) investigation in 2008 that was expanded in April 2011. Moreover, conflict of interest issues heightened in June when the Senate Finance Committee initiated an investigation of Medtronic physician consultants for not disclosing or reporting serious complications or adverse events associated with INFUSE. To top it all off, the entire June 28, 2011, issue of The Spine Journal was devoted to INFUSE with a focus on many of these issues.
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