Providence Medical Technology Announces FDA Clearance of CAVUX® FFS-LX Lumbar Facet Fixation System for 1- and 2-Level Lumbar Spinal Fusion

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Jan 10, 2024, 06:00 ET

CAVUX FFS-LX Achieved 96% Fusion Rate Verified by Independent Core Imaging Lab in Recent Clinical Study

PLEASANTON, Calif., Jan. 10, 2024 /PRNewswire/ -- Providence Medical Technology, Inc. (PMT), a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX^® FFS-LX: Lumbar Facet Fixation System for use in lumbar spinal fusion surgery.

CAVUX® FFS-LX (Facet Fixation System, Lumbar) is a novel integrated cage and screw system to treat lumbar degenerative disc disease that is now FDA-cleared for use in lumbar spinal fusion surgery.

CAVUX^® FFS-LX is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to treat lumbar degenerative disc disease (DDD). The implant spans the facet interspace with points of fixation at each end of the construct to offer additional stabilization for 1- or 2-level lumbar interbody fusion. CAVUX^® FFS-LX may be used with or without pedicle screws and rods and is implanted using the company's CORUS^™ Spinal System-LX tissue-sparing access and spinal fusion system.

The clearance marks the company's expansion into the $2 billion lumbar spine market characterized by a higher surgical failure rate than in the cervical spine. Patients who fail to fuse after a lumbar spine fusion surgery face a substantial risk of added complications, suffering, and costly revision procedures. CAVUX^® FFS-LX was designed to offer increased stabilization following lumbar fusion procedures in order to increase fusion rates and reduce future complications and reoperations.

The clearance was supported by clinical study data demonstrating a strong safety and efficacy profile. Summary clinical study data reviewed by the FDA in considering the clearance included:

57 patients were evaluated with a median follow-up of 30 months. The median age was 45, the median body mass index was 30, and 68% of subjects reported nicotine use as a risk factor.
96% of levels were determined to be fused as defined by a range of motion less than 5° on flexion/extension x-rays assessed by an independent core imaging lab.
Clinically meaningful improvement in pain was achieved in 79% of subjects.

"At Providence, we are driven to improve clinical outcomes and prevent surgical failures for high-risk patients," commented Jeff Smith, Co-founder and CEO of Providence Medical Technology. "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. We are excited to be launching into the lumbar market and provide high-risk patients a new option for a fusion success."

Joseph O'Brien, MD, a leading orthopedic spine surgeon specializing in minimally invasive spine surgery, and founder of the Washington Spine and Scoliosis Institute commented, "I am excited about the FDA clearance of CAVUX FFS-LX as a treatment option for patients treated with lumbar fusion for degenerative disc disease. The implant provides increased stabilization at the lumbar facet level for minimally invasive fusion procedures. This new option will expand the spine specialist's treatment arsenal and likely lead to increased fusion rates for patients. I have seen excellent results from this technology in challenging fusion patients."

For more information and full product indications visit providencemt.com/products-cavux-ffs-lx/

About Providence Medical Technology, Inc.

Providence Medical Technology, Inc. is a leading medical device company focused on advancing spine surgery technologies. Its commitment to improving clinical outcomes and reducing failures in high-risk spinal surgery has led PMT to be at the forefront of developing innovative solutions like CAVUX^® FFS-LX. The company's comprehensive range of products, including CORUS^™ Spinal Systems, CAVUX^® Facet Fixation Systems, and ALLY^® Bone Screws and Facet Screws underscores its dedication to excellence in spinal care.

SOURCE Providence Medical Technology, Inc.