Medtronic Achieves Major Milestone in INFUSE™ Bone Graft Study, Prepares for FDA Premarket Approval Submission

Reuters
2025/07/24
Medtronic Achieves Major Milestone in INFUSE™ Bone Graft Study, Prepares for FDA Premarket Approval Submission

Medtronic plc, a global leader in healthcare technology, has announced a significant milestone in the regulatory review process for its INFUSE™ Bone Graft for Transforaminal Lumbar Interbody Fusion $(TLIF)$ procedure. Following a successful interim analysis, the independent Data Monitoring Committee recommended stopping further enrollment in the ongoing randomized controlled trial, citing early success. Medtronic is now preparing a Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) to continue advancing this innovative spine surgery technology. Additionally, the company plans to apply for a New Technology Add-on Payment $(NTAP)$ with the U.S. Centers for Medicare & Medicaid Services, aiming to enhance the economic value of this innovation. This progress underscores Medtronic's commitment to bringing transformative technology to patients efficiently and responsibly.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Medtronic plc published the original content used to generate this news brief on July 24, 2025, and is solely responsible for the information contained therein.

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