FDA Panel Votes to Recommend Approval for Medtronic's Amplify Spine Device

Laura Dyrda -   Print  |
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After the Food and Drug Administration initially expressed concern about the high cancer rates among clinical study patients receiving Medtronic's Amplify for posterlateral lumbar fusion, the FDA's Orthopaedic and Rehabilitation Devices panel voted 6-5 in favor of approval, according to a Wall Street Journal report.

Amplify is a vertebrae stabilizing device for the lower back in patients with degenerative disc disease. In the initial Medtronic study, the protein used in Amplify to aid in forming new bone may have cased an increased risk of cancer in receiving patients, as 1.7 percent of the patients exposed to Amplify reported developing cancer compared to the 1.3 percent of patients in the control group.

The Orthopaedic and Rehabilitation Devices panel, a panel of non-FDA medical experts, was asked to review the product and make a recommendation to the FDA regarding Amplify's approval. Six panel members voted to approve the device, stating "reasonable assurance" of the device's safety and effectiveness. Five voted against FDA approval and three abstained from voting.

Read the Wall Street Journal report on the Orthopaedic and Rehabilitation Device panel's decision.

Read other coverage on Medtronic devices:

- Cancer Rates in Medtronic's Amplify Spine Device Study Concerns FDA

- Medtronic Launches SOVEREIGN Spinal System

- Medtronic Launches TSRH 3Dx Spinal System

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