Medtronic Spinal Product Not Approved by FDA

The medical device giant said that it is "in active dialogue" with the FDA to address issues with the Amplify product; an FDA panel last year gave the product mostly high ratings but noted a higher incidence of cancer in patients treated with it.

Medtronic just received disappointing news from the U.S. Food and Drug Administration (FDA) about a product that it hoped to bring to market.

In a Wednesday filing with the U.S. Securities and Exchange Commission, the Fridley-based medical device maker said that the FDA sent a letter indicating that the agency couldn't approve Medtronic's Amplify spinal product without additional information from the company.

“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. The company didn't provide details about what was in the letter or what additional information the FDA is seeking.

The Amplify product fuses the lower spine for patients who have degenerative disc disease. It contains a genetically engineered form of a protein used to help fuse vertebrae by promoting bone growth-and Medtronic has billed it as a safe and effective alternative to standard spinal fusion surgery in which a piece of a patient's hip bone is implanted in the spine.

In July, the FDA's Orthopaedic and Rehabilitation Devices panel rated it on three key measures-safety (nine voted for, four voted against, and one abstained), effectiveness (10 voted for, three voted against, and one abstained), and benefits outweighing risk (six voted for, five voted against, and three abstained).

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 get FDA approval.

According to the Star Tribune, J.P. Morgan Chase & Company analyst Michael Weinstein told investors that he views “the odds of a reversal following the issuance of the letter as low.”

News about the Amplify product comes the same week that Medtronic announced that it had resolved two FDA warning letters that it received following inspections of two facilities-a Mounds View facility that serves as the headquarters of the cardiac rhythm disease management business and a Juncos, Puerto Rico facility that manufactures products for the neuromodulation, diabetes, and cardiac rhythm disease management businesses.

In late February, Medtronic announced plans to reduce its global work force by 4 to 5 percent, or 1,500 to 2,000 positions during the fiscal fourth quarter, which ends in April. The company said at the time of the announcement that the cuts would enable it “to align its cost structure to current market conditions and continue to position Medtronic for long-term sustainable growth.”

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.