Medtronic has announced that an independent Data Monitoring Committee (DMC) reviewed the initial interim analysis and confirmed that the randomised controlled trial of INFUSE Bone Graft in the transforaminal lumbar interbody fusion (TLIF) procedure for use in spine surgery achieved predefined early success criteria.
This move prompted a recommendation to suspend further participant enrolment in the trial.
The multicentre, prospective trial assessed the effectiveness and safety of INFUSE Bone Graft in TLIF procedures for those with degenerative lumbar spine conditions.
The company is currently gearing up for a premarket approval submission to the US Food and Drug Administration (FDA).
In April, the US regulator approved a protocol change that decreased the overall size of the sample and adopted a Bayesian adaptive design for interim endpoint analysis.
The trial continued assessing two dose levels of the bone graft and included both PEEK and titanium cages to enhance wider clinical relevance.
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By GlobalDataIn April 2024, the FDA granted a breakthrough device designation for the INFUSE Bone Graft for TLIF. This status facilitates prioritised FDA review and increased collaboration during development.
According to the company, TLIF is a surgical procedure that stabilises the lower back by removing a damaged disc, inserting a cage with bone graft material, and fusing adjacent vertebrae with screws and rods to relieve pain from conditions such as degenerative disc disease or disc herniation.
The company also plans to apply for a New Technology Add-on Payment from the US Centers for Medicare & Medicaid Services following the PMA submission.
Medtronic’s clinical, medical, regulatory affairs and health economics vice-president Dave Breiter said: 鈥淥ur teams are deeply dedicated to seeing this process through to completion.
鈥淲e 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.鈥�
Recently, the company鈥檚 MiniMed 780G system received European CE Mark approval to expand the indications for use to those who are aged two years and above, during pregnancy, and for those with type 2 insulin-requiring diabetes.
