Omar Ishrak, chairman and CEO of Medtronic, responded to a series of articles attacking the company's original trials and promotion of recombinant human bone morphogenic protein-2, saying that integrity and patient safety are his highest priorities, according to a company news release.
Mr. Ishrak, who assumed his position as CEO earlier this year, responded to an articles in The Spine Journal that accuse the company of removing data about adverse events when it publicly released studies about its product, Infuse. The company did provide the information about adverse events to the FDA during the clearance process, which took place in 2002.
Mr. Ishrak said, "While 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 information available to physicians today through the instructions for use brochure attached to each product sold.
"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. We remain committed to ongoing study of the safety and efficacy of rhBMP-2, especially in applications not covered by FDA labeling."
The articles also raised questions about conflict of interest among the surgeons participating in the company-sponsored studies, and Mr. Ishrak said Medtronic will continue to investigate the conflicts, refine company policies and strive for ethical and transparent business practices.
Read the release on Omar Ishrak's defense of Infuse.
Related Articles on rhBMP-2:
NASS: BMP Use in Spinal Fusion May Cause Male Infertility
Senate Investigates Medtronic's Influence Over Surgeons Studying Infuse
Dr. Eugene Carragee: Industry-Sponsored Reports Lack Serious Complications of BMP Use
Mr. Ishrak, who assumed his position as CEO earlier this year, responded to an articles in The Spine Journal that accuse the company of removing data about adverse events when it publicly released studies about its product, Infuse. The company did provide the information about adverse events to the FDA during the clearance process, which took place in 2002.
Mr. Ishrak said, "While 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 information available to physicians today through the instructions for use brochure attached to each product sold.
"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. We remain committed to ongoing study of the safety and efficacy of rhBMP-2, especially in applications not covered by FDA labeling."
The articles also raised questions about conflict of interest among the surgeons participating in the company-sponsored studies, and Mr. Ishrak said Medtronic will continue to investigate the conflicts, refine company policies and strive for ethical and transparent business practices.
Read the release on Omar Ishrak's defense of Infuse.
Related Articles on rhBMP-2:
NASS: BMP Use in Spinal Fusion May Cause Male Infertility
Senate Investigates Medtronic's Influence Over Surgeons Studying Infuse
Dr. Eugene Carragee: Industry-Sponsored Reports Lack Serious Complications of BMP Use