Medtronic CEO Responds to Senators Regarding Spine Surgery Product

Omar Ishrak, chairman and CEO of Medtronic Inc., has responded to U.S. Senate Finance Committee concerns regarding the Infuse Bone Graft. The concerns, which include unrevealed complications during clinical trials, were raised in the June issue of the Spine Journal.

“While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the [U.S. Food and Drug Administration (FDA)] in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold,” Ishrak said in a news release. “Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications.”

The study estimates that the rate of adverse events associated with the use of the device in spinal fusion ranges from 10 to 50 percent, depending on the approach. Additionally, there is a 40 percent greater risk of adverse events with rhBMP-2 compared with controls in the early postoperative period, including life-threatening events after anterior cervical fusion, according to the study. A higher incidence of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation after anterior interbody lumber fusion also was reported.

“For several years Medtronic has been leading the industry in reforms designed to eliminate or mitigate conflicts of interest. We will continue to investigate questions surrounding researchers’ potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices,” Ishrak concluded.