Medtronic’s Infuse bone graft earned the FDA’s premarket approval for one- and two-level transforaminal lumbar interbody spinal fusions.
The expanded approval allows use with PEEK and titanium interbody cages, according to a Feb. 17 news release. Infuse is now the only PMA-approved growth factor bone graft for ALIF, OLIF and TLIF.
“The FDA approval of INFUSE bone graft for TLIF is a major step forward for spine care,” spine surgeon and Medtronic consultant Christopher Shaffrey, MD, said in the release. “he strength of the clinical data, the versatility across levels and implant types, and the consistency of outcomes provide surgeons with a highly validated option for complex fusion cases. Having a PMA-approved biologic solution available for ALIF, OLIF, and now TLIF enhances our ability to tailor treatment to the individual needs of each patient.”
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
