CHARLOTTESVILLE, VA., April 13, 2021—RIVANNA®, developers of world-first, imaging-based medical solutions, announces that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued a Medtech innovation briefing (MIB245) on the use of Accuro® and its benefits related to spinal or epidural anaesthesia administration in people with obesity.
Clinical studies, including two randomized controlled trials, with a total of 423 adults needing epidural or spinal anaesthesia, were thoroughly reviewed in the MIB. Based on the evidence evaluated, Accuro accurately located the intervertebral space and required fewer needle insertions compared with palpation alone in people with obesity irrespective of provider experience level or type of neuraxial anaesthesia performed. In a randomized controlled trial conducted at the Rizzoli Orthopedic Institute in Bologna, Italy, researchers reported that Accuro reduced need redirects by 48% for experienced anaesthesia providers compared to the traditional palpation-based approach in obese patients undergoing orthopedic surgery (D. Ghisi et al., 2019). Using Accuro’s AI-Based SpineNav3D™ technology, resident physicians with minimal training in ultrasonography showed a reduction in needle insertions(21%; p=0.025), needle passes (38%; p=0.030), and difficult spinal (58%) compared with palpation alone in an obese population undergoing scheduled cesarean delivery (Singla et al., 2019).Accuro’s proprietary technology improves localization of the desired intervertebral space for first-attempt success during epidural or spinal anaesthesia. Multi-Frequency BoneEnhance® Image Reconstruction provides enhanced visualization of lumbar and thoracic bony anatomy. Using these identified bony landmarks, SpineNav3D™ AI-BasedSpine Recognition guides users with automated identification of spinal midline, epidural space, and depth.
Commentary from clinical experts included in the briefing stated that Accuro could replace the standard of care; its innovation makes finding the intervertebral space easy due to the vertebrae image display superimposed on an ultrasound image, and that using Accuro requires minimal training. Quoted from the MIB, “This device could reduce procedure time and discomfort because of the need for fewer needle insertions. Reduced needle insertion time could mean faster pain relief in labour and less delay in using spinal anaesthesia for urgent caesareans. Less delay in anaesthesia could also reduce time-related neonatal morbidity and the risk from having general anaesthesia.”
Andrew Hatton, Business Development, EMEA at RIVANNA, commented, “We’re thrilled to see the NICE MIB on the use of Accuro. NICE uses a meticulous approach evaluating economic and clinical outcomes and is considered a global authority in assessing new technologies’ effectiveness. This briefing will help healthcare decision-makers in the UK and beyond who are considering the adoption of novel medical technologies like Accuro.” The device is currently being used in five NHS Trusts and is selling in more than 24 counties.
Medtech innovation briefings (MIBs) are NICE advice. They are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies.
About RIVANNA
RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world’s first spinal navigation device designed to improve the safety, speed and efficiency of spinal needle guidance procedures. RIVANNA’s revolutionary platforms feature BoneEnhance®, Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.
