The Food and Drug Administration has declined to approve a spinal product that Medtronic Inc. hoped to bring to market, the Fridley-based company said Thursday.
Medtronic said it received a letter saying the agency could not approve Amplify, a bone graft product, without more information from the company, according to documents filed with the U.S. Securities and Exchange Commission.
The company said it is working with the FDA to resolve its concerns. FDA reviewers had brought up issues regarding the product's possible cancer risks in a report released last year.
"We are in active dialogue with the FDA to address the issues in its letter, have been given the opportunity by the FDA to provide further information relevant to these issues, and are hopeful that the FDA will ultimately approve Amplify," Medtronic said in the regulatory filing.
Amplify is used in spine fusion surgery, a procedure that attempts to stimulate bone growth between the vertebrae, eliminating back pain. Each year, some 300,000 spine fusion surgeries are performed in the United States, often with a similar bone-growth product made by Medtronic called Infuse that regulators approved in 2002.
Last year, an FDA advisory panel recommended approval of Amplify on a split vote. Six members of the panel voted that the benefits of the product outweighed the risks, five voted that the benefits didn't outweigh the risks and three abstained on that question.
Separate votes on the product's safety and effectiveness passed by wider margins.
If Amplify is ultimately approved by the FDA, it could be a boost to the company's sluggish spine business. Leerink Swann & Co. analyst Rick Wise wrote in a report last year that Amplify could bring in as much as $175 million in annual sales.
