CHARLOTTESVILLE, VA, SEPTEMBER 13, 2021 — RIVANNA®, developers of world-first, imaging-based medical solutions, today announced the results of a recent randomized controlled trial (RCT) showing that Accuro® automated spinal navigation system significantly enhanced the efficacy and safety of combined spinal-epidural anesthesia (CSEA) placement compared to the traditional palpation-based approach in obese patients undergoing cesarean delivery. The study, published in the Journal of Anesthesia, included 80 patients scheduled for elective cesarean delivery with a body mass index (BMI) above 30 kg/m and gestational age greater than 37 weeks.
Compared to traditional palpation for bony landmarks, the Accuro-guided technique provided significant first-insertion success rates (72.5 percent vs. 40.0 percent), decreased needle redirections (40.0 percent vs. 72.5 percent), and reduced incidences of paresthesia (7.5 percent vs. 45 percent), even for experienced providers.
“Numerous studies have confirmed the effectiveness and safety of the Accuro-guided technique over the palpation-based approach for spinal placement or epidural catheterization,” commented Will Mauldin, Ph.D., co-founder, and CEO of RIVANNA. “This study is notable because it detailed a statistically significant reduction in paresthesia, a complication which has not been studied specifically in prior Accuro trials.”
Clinical trials and a large volume of clinical research have demonstrated the superiority of neuraxial image guidance resulting in the publication of meta-analyses and the integration of neuraxial imaging into many clinical- society guidelines. The use of pre-procedure ultrasound has been associated with a reduced risk of failed epidural analgesia and complications. However, conventional ultrasound is not designed to image spinal bone structures; instead, it is intended for soft-tissue imaging applications such as the imaging of blood vessels and nerve bundles. This technical limitation contributes to the difficult learning curve associated with neuraxial ultrasound competency using conventional equipment.
Quoted from the RCT, “The Accuro ultrasound-based device represents a potential to bridge this gap by reducing the learning curve of neuraxial ultrasound through automated image interpretation and increasing accessibility with a handheld, low-cost system.”
Providers with even minimal ultrasound experience can take advantage of Accuro’s safety benefits and effective image guidance. BoneEnhance® Multi-Frequency Image Reconstruction optimizes ultrasound for the visualization of bony versus soft-tissue anatomy and SpineNav3DTM AI-Enabled Spine Recognition provides real-time confirmation of interspaces within the lumbar ultrasound image and automatically annotates the epidural depth measurement.
Conducted in China at Shanghai First Maternity and Infant Hospital, the trial is registered at chictr.org.cn (ChiCTR1900024017).
RIVANNA is elevating global standards of care through the development and commercialization of world-first imaging-based medical technologies, including BoneEnhance® Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft-tissue anatomy, and SpineNav3D™ AI-Enabled SpineRecognition, which automates ultrasound image interpretation. RIVANNA’s clinician-assistance solutions improve decision-making, clinician workflows, health outcomes, and patient satisfaction. Headquartered in Charlottesville, VA, RIVANNA is privately held and operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. For more information, visit rivannamedical.com