NeuraMedica has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its DuraFuse dural clips which, according to the firm, are designed to allow for fast and secure dural closure.
Neil Roundy, a neurosurgeon at Oregon Neurosurgery (Springfield, USA) and co-founder and chief medical officer of NeuraMedica, said: “The idea for a dural clip came to me when I was a neurosurgery resident at Oregon Health and Science University (Portland, USA). I realised how time-consuming suturing the dura can be and I knew there had to be a better way, especially in cases with minimal access.”
DuraFuse dural clips allow neurosurgeons and orthopedic spine surgeons to close incidental and planned spinal durotomies in a fraction of the time it would take to suture the dura, say NeuraMedica.
DuraFuse Dural Clips are a non-penetrating, bioabsorbable, imaging-compatible device designed to create a fast and secure dural closure in both open and tubular retractor procedures of the spine, saving surgeons and hospitals significant time and money.
Rachel Dreilinger, co-founder and chief executive officer of NeuraMedica, commented: “DuraFuse dural clips represent a significant advance for surgeons who need to close spinal dura quickly. We are thrilled to receive FDA 510(k) clearance and bring DuraFuse to market.”
Full commercial launch of the DuraFuse dural clips is expected in late 2022.
“We are very excited with the initial response we are seeing for DuraFuse. This product represents a simple, safe, and effective way for surgeons to close the dura,” added Chris Eddy, vice president of sales at NeuraMedica.