The U.S. Food and Drug Administration voted in favor of Medtronic Inc.'s experimental Amplify spinal implant this week, in a 6-5 vote with three abstaining, after concerns were raised about the product's safety .

FDA's Orthopaedic and Rehabilitation Devices panel looked at data regarding the product from a trial, and found the product safe and effective for fusions of the lower spine in patients with degenerative disc disease, according to the company.

The protein used in Amplify to stimulate bone growth -- recombinant human bone morphogenetic protein-2, or rhBMP-2 -- is used in the company's InFuse device, which is already on the market for spinal surgery.
In a letter to investors, health care investment bank Leerink Swann wrote that it is "cautiously optimistic" about the product's approval, which could happen within six to 12 months. If approved, Leerink Swann expects a significant boost in the company's sales.

There were concerns regarding elevated cancer risk and risks to women's reproductive health.

In one of the clinical trials, 3.8 percent of patients using Amplify developed cancer within two years, compared with 0.9 percent in the control group. But because the cancers developed were different types, the panel felt it wasn't a result of Amplify, according to media reports.

"We will continue to collaborate closely with the FDA to develop the path forward," said Tom McGuinness, Medtronic vice president and general manager of the company's biologics panel, in a statement. "The potential approval of [Amplify] will further strengthen our position as the market-leading provider of a comprehensive portfolio of bone grafting options."

Spinal products accounted for $3.5 billion of Medtronic's $15.8 billion in sales during the 2010 fiscal year.

More Industry Headlines