Medtronic Device Faces Uncertain Approval After Vote

Medtronic Inc.’s experimental spinal device may face a battle for U.S. regulatory approval after a narrow 6-5 vote from a federal advisory panel that the device’s benefits outweigh its risks.

The device, Amplify, is used for spinal fusion surgery on the lower back. It works well enough to overcome concerns raised by studies that linked the product to a cancer risk, six scientific advisers to the Food and Drug Administration said yesterday. Five panelists disagreed, and three others abstained. While the FDA usually follows panel recommendations, it isn’t required to do so.