by INFUSE, Medtronic’s blockbuster bone morphogenic protein (BMP), is under fire. Safety issues originating from use ofINFUSE in the cervical spine mushroomed into allegations of off-label promotion, triggering a DOJ investigation in 2008 that was later expanded in April 2011. 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 28th issue of *The Spine Journal* was devoted to INFUSE with a focus on many of these issues.
Off-Label Crack Down
In an effort to take the high road and save INFUSE from a precipitous fall, Medtronic announced that it will make all patient data, both published and unpublished, and FDA-filed adverse event reports available to Yale University for an independent and comprehensive review of the entire body of evidence on the BMP product. With a $2.5M grant, Yale will conduct two fully independent, third-party systematic reviews of the safety and effectiveness of INFUSE. Medtronic is hoping that the Yale studies, results of which should be available in mid-2012, will quickly put safety and trust issues to rest before mounting legal issues (possible class action lawsuits, Congress and DOJ investigation) take hold. In the meantime, regulators and payors are cracking down on off-label use and some hospitals are restricting access to INFUSE requiring surgeons to seek an alternative as a cost-saving measure.
With off-label use as high as 85% INFUSE is approved for ALIF spinal fusion, tibial fractures and dental), Medtronic recently initiated a 534-patient IDE study evaluating the safety and efficacy of INFUSE in conjunction with the CAPSTONE and CD HORIZON systems for 1-2 level fusion using a TLIF approach in patients with lumbrosacral degenerative disease. These data will be used to expand approval of INFUSE in spinal fusion beyond the narrow indication of single-level ALIF. However, this is not Medtronic’s first attempt at gaining approval for its BMP for broader spinal indications, and this time the bar is set much higher. Last year, the Company tried unsuccessfully to obtain approval for Amplify, a higher dose of BMP-2 on a synthetic carrier, for posterolateral fusion, however, the issue of cancer reared its ugly head. As a result, the Company received a non-approval letter in December.
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