Medtronic Amplify spinal product failed to gain FDA approval

The company’s Infuse bone-graft device is reportedly being investigated by the Department of Justice; meanwhile, its Amplify spinal product, which is similar to the Infuse bone graft, failed to gain FDA approval.

Fridley-based Medtronic, Inc., is facing challenges from regulators over two of its spinal products—one that failed to gain approval from the U.S. Food and Drug Administration (FDA) and another that is reportedly being investigated by the U.S. Department of Justice.

According to The New York Times, a longtime investigation into the marketing of Medtronic’s Infuse bone-graft device is widening, and the Department of Justice has recently contacted additional doctors to get information for the investigation.

Unnamed sources familiar with the investigation told The New York Times that prosecutors have sought records from United States Army researchers who were involved in studies of Infuse, which has been used to treat severely wounded American soldiers.

The extent of the investigation is not clear, but The New York Times reports that investigators have also subpoenaed records from academic researchers and doctors outside the military who worked on other Medtronic-funded studies regarding the device.

Last month, the company said in regulatory filings that it received a letter from the FDA saying that the agency couldn’t approve the product without additional information from Medtronic.

The Amplify product fuses the lower spine for patients who have degenerative disc disease. After two years, surgeries were successful in 61 percent of Amplify patients compared with 56 percent for people who had standard procedures using a bone graft from the hip, the FDA panel found. The panel noted a higher incidence of cancer in patients treated with Amplify—prompting some experts to speculate that the device may not gain FDA approval.

Medtronic said that it is in talks with the FDA to address the issues in the letter and is “hopeful” that the FDA will ultimately approve the device.

Medtronic is the world’s largest medical device company and Minnesota’s seventh-largest public company based on revenue, which totaled $15.8 billion in its most recently completed fiscal year.