![]() ![]() "Medtronic continues to invest in scientific evidence on Infuse to continue adding to the growing body of clinical data, and we believe these trials will generate additional data to expand indications, increase access to surgeons, and alleviate pain and restore health for patients around the world." "With 17 years of clinical use, Infuse Bone Graft has become one of the most extensively-researched biologic technologies commercially available today," said Jacob Paul, senior vice president and president of Medtronic's Spine division, which is part of the Restorative Therapies Group. ![]() The company is currently enrolling its prospective pilot PLF clinical trial and is working with the FDA to incorporate retrospective safety and effectiveness data sufficient for indication expansion in PLF. In 2017, Medtronic announced the FDA approval of a separate clinical trial to study Infuse Bone Graft in Posterolateral Fusion (PLF) procedures. Medtronic has initiated site recruitment for the TLIF clinical trial with the potential to enroll up to 50 sites with over 1,000 patients. This study has the potential to add to the broader clinical and scientific evidence regarding use of Infuse, and may allow surgeons to better understand its safe and effective use in TLIF procedures.” “When considering the patient, site, and procedure, Infuse can be a powerful option in a spine surgeon’s armamentarium. Smucker, an orthopedic spine surgeon with the Indiana Spine Group and principal investigator in the clinical trial. "The potential to expand the indications for use of Infuse in posterior spine procedures may give a broader group of patients access to this novel biologic technology," said Dr. It is used to treat certain painful conditions of the lumbar-or low back-region of the spine. Or joins-bones of the spine through a posterior approach. Food and Drug Administration (FDA) approval of a prospective, randomized pivotal clinical trial for the use of Infuse Bone Graft in Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. ![]()
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