Medtronic Inc.’s (NYSE:MDT) new chairman and CEO Omar Ishrak issued his first official public statement in response to the kerfuffle over the Infuse bone growth trials.
A critical review of the company’s spinal fusion product (rhBMP-2) is set to be published in the Spine Journal this week, alleging that Medtronic’s Infuse product causes excess bone growth in the spinal canal and that researchers on the company payroll covered it up.
In his first official statement as company CEO, Ishrak defended Medtronic’s data while maintaining the company’s commitment to eliminating conflicts of interest.
"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 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 the 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 allegations continue to stack the deck against the Infuse implant, which has been widely used to fuse spinal vertebrae during surgeries since 2002.
"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 said.
He was more succinct on his Twitter account. " Integrity and patient safety will always be my number one priority," he tweeted.
This is the company’s second statement in regard to the Infuse bone growth allegations in the past five days.