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Medtronic’s Amplify spine implant dealt FDA setback

The FDA tells the Fridley-based company that it won’t approve Amplify, which uses a protein to promote bone growth, without additional information from Medtronic.

Medtronic  has been dealt a setback in efforts to win U.S. Food and Drug Administration approval of its Amplify spine implant.

Medtronic disclosed in a Thursday filing with the U.S. Securities and Exchange Commission that the FDA sent Medtronic a letter in the most recent quarter advising the Fridley-based company that it wouldn’t be able to approve Amplify without additional information from Medtronic.

An FDA panel in July recommended approval of Amplify, but was split over possible cancer risks involving the implant, which uses a protein to promote bone growth.

The news came on the same day Medtronic launched its Atlantis Vision Elite Anterior Cervical Plate System in the United States.

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The titanium implant is used to treat patients who suffer from degenerative disc disease affecting the neck. It’s meant to provide more stability during spinal fusion, which involves joining two adjacent vertebrae together. Medtronic says the newest Atlantis system is innovative because it combines two existing Medtronic technologies in one plate: There’s a quarter-turn locking mechanism designed to prevent screws from backing out or loosening during fusion, and the plate is designed in a way that allows surgeons to have a better view of the spine.

Medtronic’s Atlantis system of products have been in clinical use for 12 years.