The Food and Drug Administration has cleared for commercial sale in the United States a novel form of surgical clips for dural closure. The brand name of the product is DuraFuse™ Dural Clips and it is manufactured by Oregon City, Oregon-based NeuraMedica, Inc.
FDA Clears Novel Surgical Clips for Dural Closure
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Secondary#autosuturemodifiedvcsclip#durafuse#neuramedica
According to the company, the DuraFuse Dural Clips are a “bioabsorbable surgical clip for durotomy closure in spinal surgery.”
According to the FDA document, the DuraFuse Clips are “indicated for open and tubular retractor procedures of the spine in the prone position for approximation/attachment and/or closure of the dura matter in neurosurgical and orthopedic spine procedures.” The dura matter surrounds and protects the brain and spinal cord.
The predicate device that NeuraMedica is claiming substantial equivalence to was originally cleared in 1996. It is United States Surgical Corporation’s Auto Suture Modified VCS Clip.
OTW spoke with NeuraMedica Co-Founder and CEO Rachel Dreilinger about what sets DuraFuse Dural Clips apart from the competition. Dreilinger explained, “The standard-of-care for durotomy closure is typically suture, often overlaid with dural sealants to create a watertight closure. Suture lacerates the dura which can cause leakage and it can be difficult and time-consuming to perform. Existing dural closure clips are usually metallic, permanent, and non-absorbable. There is the potential for imaging artifacts and other imaging issues with metallic clips and some may also puncture the dura.”
Dreilinger continued, “In contrast, DuraFuse Dural Clips are the only bioabsorbable, non-penetrating, and imaging-compatible clips available on the market indicated for dural closure. They dissolve in the body over time, are radiolucent and MRI-Safe, and they do not create imaging artifacts. They eliminate any leakage caused by suture holes and can be used in procedures with minimal accessibility without using dural sealants. DuraFuse is simple to use and allows for dural closure in a fraction of the time of suture.”
OTW also spoke with Dreilinger about NeuraMedica’s goals for the remainder of 2022. Dreilinger told OTW, “NeuraMedica is focused on achieving successful early alpha cases and preparing for our full market launch at the end of 2022.”
Dreilinger added, “We will be attending a North American Spine Society (NASS) meeting in October in order to introduce this product to neuro- and orthopedic spine surgeons.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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