Medtronic (NYSE: MDT) announced a milestone in bringing its Infuse bone graft for TLIF to the U.S. market.
Following the first interim analysis, the independent Data Monitoring Committee (DMC) determined that the company’s FDA investigational device exemption (IDE) study of Infuse for transforaminal lumbar interbody fusion (TLIF) procedures met the predefined criteria for early success.
Based on this assessment, the DMC recommended stopping further enrollment. Medtronic said it now has the process underway to prepare a premarket approval (PMA) submission to the FDA.
The study evaluates the safety and effectiveness of Infuse in TLIF procedures with patients with degenerative lumbar spine conditions. In April, the FDA approved a protocol amendment reducing the overall sample size. This amendment also introduced an adaptive design for interim analysis. The study continued to evaluate two dose levels of Infuse and incorporated both PEEK and titanium cages to support broader clinical applicability.
Infuse for TLIF initially received FDA breakthrough device designation in April 2024. A new indication could expand treatment options for spine surgery patients if approved, Medtronic says. The company also aims to file for new technology add-on payment (NTAP) with CMS for reimbursement.
“Our teams are deeply dedicated to seeing this process through to completion. We are prepared to work collaboratively with the FDA to address all aspects of the PMA submission and ensure we deliver a high-quality application that meets the highest standards,” said Dave Breiter, VP of clinical, medical, regulatory affairs and health economics for the Cranial & Spinal Technologies business at Medtronic.
The breakthrough device designation news comes eight years after Medtronic agreed to settle nearly all of the thousands of lawsuits claiming that the company promoted off-label uses of Infuse that resulted in personal injury.
