Oregon Metropolis, Oregon, August 31, 2022 /OrthoSpineNews/ – NeuraMedica Inc., a medical machine firm creating progressive merchandise for neurosurgery, has acquired 510(ok) clearance for DuraFuse™ Dural Clips from the U.S. Food and Drug Administration (FDA).
“The concept for a dural clip got here to me after I was a neurosurgery resident at OHSU [Oregon Health & Science University]. I noticed how time-consuming suturing the dura may be and I knew there needed to be a greater method, particularly in circumstances with minimal entry.” stated Neil Roundy MD, a neurosurgeon at Oregon Neurosurgery in Springfield, Oregon and Co-Founder and Chief Medical Officer (CMO) of NeuraMedica.
DuraFuse Dural Clips permit neurosurgeons and orthopedic spine surgeons to shut incidental and deliberate spinal durotomies in a fraction of the time it might take to suture the dura. The dura mater, which covers and protects the mind and spinal cord, should be repaired as rapidly as attainable when opened to stop cerebrospinal fluid (CSF) leakage. Conventional dural closure with suture may be time-consuming and troublesome. Metallic clips are everlasting and may trigger imaging artifacts. DuraFuse Dural Clips are a non-penetrating, bioabsorbable, imaging-compatible machine designed to create a quick and safe dural closure in each open and tubular retractor procedures of the spine, saving surgeons and hospitals vital money and time.
“DuraFuse Dural Clips characterize a major advance for surgeons who want to shut spinal dura rapidly. We’re thrilled to obtain FDA 510(ok) clearance and produce DuraFuse to market,” stated Rachel Dreilinger, Co-Founder and Chief Govt Officer (CEO) of NeuraMedica.
NeuraMedica is wanting ahead to our full business launch in late 2022. The corporate plans to attend the Nationwide Affiliation of Backbone Specialists (NASS) Annual Assembly in Chicago, Illinois in October 2022.
“We’re very excited with the preliminary response we’re seeing for DuraFuse. This product represents a easy, protected, and efficient method for surgeons to shut the dura,” stated Chris Eddy, VP of Gross sales at NeuraMedica.
To study extra about DuraFuse Dural Clips, go to NeuraMedica.com/durafuse-spinal-dural-clip.
About NeuraMedica Inc. NeuraMedica is a medical machine firm specializing in progressive merchandise for neurosurgery. NeuraMedica is a woman-owned and Native-owned (Diné) firm based in 2014 by biomedical engineer Rachel Dreilinger and neurosurgeon Neil Roundy MD to develop a simple answer to dural restore that advantages surgeons, hospitals, and sufferers. Commercialization of this product was made attainable by funding from the Nationwide Science Basis (NSF), the Nationwide Institutes of Health – Nationwide Institute of Neurological Issues and Stroke (NIH NINDS), OHSU Oregon Medical and Translational Analysis Institute (OHSU OCTRI), Oregon Nanoscience and Microtechnologies Institute (ONAMI), Enterprise Oregon, and Alignment Ventures. To study extra about NeuraMedica, go to NeuraMedica.com.
NeuraMedica Inc. Contact Data: Internet: www.NeuraMedica.com
Contact: Rachel Dreilinger [Co-Founder and CEO]Cellphone: +1.503.914.0723 E mail: rachel@NeuraMedica.com
Contact: Chris Eddy [VP of Sales]Cellphone: +1.503.915.8502 E mail: chris@NeuraMedica.com