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FDA Ortho Panel Says 'No' To Medtronic DIAM Spine Device

Minimally invasive interspinous spacer did not get the support of an FDA advisory panel in the face of serious questions about Medtronic's study design.

Skepticism over clinical trial design sank Medtronic PLC’s DIAM Spinal Stabilization System at a Feb. 19 meeting of the FDA Orthopaedic and Rehabilitation Devices Panel. The majority of the 11-member panel found that the evidence did not show that the device was safe or effective, or that its benefits outweighed its risks.

The DIAM, which has been CE marked in Europe for more than a decade, is used to treat moderate degenerative disc disease in adults. Seven of the 11 panelists voted...

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