Medtronic commences new long-term study of Infuse bone graft

Medtronic has announced the commencement of a long-term clinical study programme assessing the performance of its Infuse bone graft.

The BONE study will evaluate the effectiveness of the graft in posterolateral fusion (PLF) and transforaminal lumbar interbody fusion (TLIF) spine procedures, two common types of back surgery.

The first patient has been enrolled in the PLF portion of the study, which is designed to expand the clinical understanding of the Infuse graft and to determine its efficacy, safety and health economic outcomes in PLF and TLIF spine procedures.

Over the course of ten years, approximately 40 to 50 sites and 550 to 700 patients will be involved in the trial. Results may also potentially be used to support peer-reviewed publications and regulatory filings.

Doug King, senior vice-president and president of Medtronic's spine division, said: "We're hopeful that, if successful, the trials will generate additional data to expand indications and provide surgeons with additional options to help alleviate pain and restore health for more patients."

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