PMT Nabs FDA Nod for Cavux FFS-LX: Lumbar Facet Fixation System

Providence Medical Technology (PMT), a spine surgery-focused medtech company, today announced FDA has cleared its Cavux FFS-LX: Lumbar Facet Fixation System for use in lumbar spinal fusion surgery.

The $2 billion lumbar system market is characterized, according to the company, by a higher surgical failure rate than in the cervical spine because patients who fail to fuse after a lumbar spine fusion surgery face a substantial risk of added complications, low quality-of-life, and expensive revision procedures.

PMT said it designed the Cavux FFS-LX system to offer increased stabilization following such procedures in order to increase fusion rates and reduce complications and revisions. The implant is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to treat lumbar degenerative disc disease. It spans the facet interspace with fixation points at each end of construction to offer added stabilization for one or two level lumbar interbody fusion. Of note, Cavux FFS-LX can be used with or without pedicle screws or rods and is implanted using PMT’s Corus Spinal System-LX tissue-sparing access and spinal fusion system.

The FDA clearance was reportedly supported by clinical study data that demonstrated a strong safety and efficacy profile. The study included 57 patients that had a median follow-up of 30-months. The median age of participants was 45, median body mass index was 30, and 68% reported nicotine use as a risk factor. Overall, 96% of levels were determined to be fused, which was defined as a range of motion less than 5° on flexion/extension x-rays and were assessed by an independent core imaging lab. The trial ended with 79% of subjects achieving clinically meaningful improvement in pain.

“Cavux FFS-LX builds off our successful cervical platform and applies the same principles to the lumbar spine where the challenge of treating high-risk patients is even more pronounced,” said Jeff Smith, co-founder and CEO of PMT. " We are excited to be launching into the lumbar market and provide high-risk patients a new option for a fusion success."