Medtronic (NYSE: MDT) announced a key milestone in its FDA investigational device exemption (IDE) study for Infuse bone graft use in transforaminal lumbar interbody fusion (TLIF) surgeries. Following a successful first interim analysis, the independent Data Monitoring Committee recommended halting further enrollment due to early success.
The study assesses the safety and effectiveness of Infuse in patients with degenerative lumbar spine conditions, testing two dose levels and compatibility with PEEK and titanium cages. This adaptive design and reduced sample size amendment, approved by the FDA in April, aim to broaden clinical applicability.
Medtronic is now preparing its premarket approval (PMA) submission and plans to file for new technology add-on payment (NTAP) reimbursement with CMS if approved. Infuse for TLIF holds FDA breakthrough device designation since April 2024.
“Our teams are committed to delivering a high-quality PMA submission and collaborating closely with the FDA,” said Dave Breiter, Medtronic’s VP of clinical and regulatory affairs.
This progress comes eight years after Medtronic settled lawsuits over off-label Infuse use allegations.
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