Medtronic has announced the launch of a long-term clinical study programme to collect prospective data on rhBMP-2 (Infuse) bone graft in posterolateral fusion (PLF) and transforaminal lumbar interbody fusion (TLIF) spine procedures.
The first patient has been enrolled in the PLF study at Fort Wayne Orthopedics in Fort Wayne, USA. The Spine team led by Kevin Rahn and Robert Shugart performed the procedure.
The use of Infuse bone graft in PLF and TLIF procedures is investigational only.
“Failed back surgery is a real concern with long-term implications, and successful outcomes in PLF and TLIF procedures require solid fusion,” says Brian Subach, president at The Virginia Spine Institute. “We believe there is significant data on the safety and efficacy profile of Infuse in approved ALIF and OLIF procedures, and we are hopeful this clinical study programme can generate evidence about the potential to use this important technology to help a broader group of patients.”
Infuse bone graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease, and is designed to eliminate the need to harvest bone from the patient’s body in a secondary surgical procedure.
The global clinical programme, called BONE (BMP outcomes and new evidence in PLF and TLIF procedures), is designed to expand the clinical understanding of Infuse and to evaluate efficacy, safety and health-economic outcomes for use in PLF and TLIF spine procedures. The current plan for the prospective, multicentre, ten-year programme will include approximately 40–50 sites and 550–700 patients between the pilot and pivotal studies of both procedures. The PLF pilot dosing study, which will include approximately 125 patients, will be followed by a TLIF pilot dosing study in 2018. If successful, the pilot studies would be followed by a larger pivotal study. The results may also potentially be used to support peer-reviewed publications and regulatory filings.
Doug King, senior vice president and president of Medtronic’s Spine division, which is part of the Restorative Therapies Group, says, “We are hopeful that if successful, the trials will generate additional data to expand indications and provide surgeons with additional options to help alleviate pain and restore health for more patients.”
Infuse has been the subject of controversy since a number of employees failed to report over a thousand adverse events associated with use of the product to the FDA between 2006 and 2008. The adverse events—which included four deaths—were discovered in a retrospective chart review of the product. According to a Star Tribune report, staff failed to notify the FDA about the adverse events, shutting the study down in 2008. By the time news emerged of these unreported adverse events in 2013, most of the Medtronic staff involved in the scandal had left the company, causing confusion within the company itself. Medtronic attempted to provide more adequate information regarding adverse events in a study run by Yale University, but this, too, has been the subject of some controversy. More recently in 2016, a US district court judge dismissed the accusation of several hundred plaintiffs that they have been treated off-label with the product.