Medtronic launched new long-term clinical studies to collect prospective data on posterolateral fusion and transforaminal lumbar interbody fusion procedures using Infuse Bone Graft.
Here are five things to know:
1. Surgeons used Infuse for years to promote fusion, especially in difficult-to-fuse situations. The global study aims to expand the clinical understanding of Infuse and evaluate efficacy, safety and health economic outcomes for PLF and TLIF.
2. The prospective, multicenter, 10-year program will include 40 to 50 sites and 550 to 700 patients between a pilot and pivotal study of both procedures. The PLIF pilot dosing study already began and will include around 125 patients; the TLIF dosing study will follow in 2018.
3. If the pilot studies are successful, the company plans to conduct larger pivotal studies that could support peer-reviewed publications and regulatory filings. "Infuse is one of the most extensively researched biologic agents commercially available today and Medtronic continues to invest in research of Infuse to deepen the understanding of the benefits and risks of this novel treatment," said Medtronic Spine's Senior Vice President and President Doug King. "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."
4. Fort Wayne (Ind.) Orthopedics surgeons Kevin Rhan, MD, and Robert Shugart, MD, performed the first procedure in the PLF study. Infuse application for PLF and TLIF is investigational only.
5. Medtronic placed Infuse on the market in 2002 and more than 1 million patients have been treated with the bone graft material.