The U.S. Food and Drug Administration is concerned about the high number of cancer cases reported in clinical study patients for Medtronic's Amplify, a spine device, according to a Wall Street Journal report.
Amplify is designed to stabilize lower back vertebrae in patients with degenerative disc disease and uses protein to enhance bone growth. Medtronic has been asked to submit their report to the FDA's Orthopaedic and Rehabilitation Devices advisory panel on a study which found 1.7 percent of the patients using Amplify reported having cancer as opposed to 1.3 percent of the patients in the control group. The panel is expected to comment on the statistical and clinical significance of these results as well as vote on a recommendation to the FDA concerning Amplify's approval.
Read the Wall Street Journal report on the FDA's approval concerns.
Read other coverage on FDA decisions:
- 2009 Crackdown on Pedical Screw-Based Stabilization System Negatively Impacts Small, Offlabel Manufacturers
- FDA Clears 35 Orthopedic and Spine Devices in April
- FDA Releases 21 Draft Transparency Proposals for Public Comment
Amplify is designed to stabilize lower back vertebrae in patients with degenerative disc disease and uses protein to enhance bone growth. Medtronic has been asked to submit their report to the FDA's Orthopaedic and Rehabilitation Devices advisory panel on a study which found 1.7 percent of the patients using Amplify reported having cancer as opposed to 1.3 percent of the patients in the control group. The panel is expected to comment on the statistical and clinical significance of these results as well as vote on a recommendation to the FDA concerning Amplify's approval.
Read the Wall Street Journal report on the FDA's approval concerns.
Read other coverage on FDA decisions:
- 2009 Crackdown on Pedical Screw-Based Stabilization System Negatively Impacts Small, Offlabel Manufacturers
- FDA Clears 35 Orthopedic and Spine Devices in April
- FDA Releases 21 Draft Transparency Proposals for Public Comment