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Medtronic presses on with DIAM trials

This article was originally published in Clinica

Executive Summary

Medtronic is embarking on a European study to demonstrate the benefits of its DIAM spinal stabilisation system in reducing lower back pain in standard herniectomy procedures. The trial is expected to end in 2009, with clinical endpoints of back pain relief at six months and reduction of disability at 12 months. DIAM is already CE-marked for sale in Europe, where the latest study is being performed to validate the indication, as it relates to reimbursement. Two further trials are scheduled for completion in 2009 and 2010, respectively. The product will become available in the US "at clinical trial completion" said the firm. Medtronic claims that DIAM is the only non-rigid interspinous spacer under clinical investigation.

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