Real-time needle guidance for paramedian epidural and spinal anesthesia maximizes image guidance efficiency

CHARLOTTESVILLE, VA., November 16, 2020 – RIVANNA® today announced launch of its second-generation Accuro® automated spinal navigation system, combining innovative new thoracic spine functionality with broad enhancements to its groundbreaking introductory system, which five years ago ushered in a new paradigm of ultrasound-guided epidural and spinal anesthesia placement. Accuro Lumbar and Thoracic presets, with SpineNav3DTM technology, facilitate image interpretation of individual 2D lumbar and thoracic spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D. This technology makes image interpretation and measurements of the lumbar and thoracic spine anatomy simple and accessible.

The Thoracic presetting is a logical expansion of Accuro capabilities; it adapts Accuro’s SpineNav3D pattern recognition technology with customized graphical indicators to support a paramedian placement technique with real-time needle visualization. The new functionality is based in part on Accuro’s BoneEnhance® image reconstruction technology, which improves visualization of thoracic bony anatomy and compensates for ultrasound’s inherent distortion with a 5- to 10-fold increase in bone-to-tissue contrast. Contributing to this is new bone-specific ultrasound probe technology, limiting the bone artifacts that detract from image contrast and clarity in conventional systems. Using these clearly identified bony landmarks, SpineNav3D displays the trajectory of the appropriate paramedian needle track for thoracic epidural procedures.

New patented single-use Accuro Locator® needle-guide functionality provides dedicated channels to support real-time needle guidance and prescribes the pathway or “needle-track” indicated in the Thoracic preset. Real-time needle-track and interlaminar depth indicators overlay the BoneEnhance image once spinal landmark anatomy is detected at a location enabling paramedian needle access to the interlaminar space. The user may visualize the needle, progressing along the prescribed needle-track pathway, helping anesthesia providers avoid involvement of vulnerable nearby anatomy.

Thoracic epidural analgesia (TEA) is the gold standard for treating acute pain following major thoracic and abdominal surgeries and in patients with fractured ribs. TEA is regarded as one of the most technically difficult procedures executed by anesthesiologists, in large part because epidural needle placement is guided by manual palpation of spinal bone landmarks followed by “blind” needle insertion. Palpation of spine landmarks is unreliable for identifying the epidural space (i.e. 30% accuracy) and results in high TEA failure rates (15 – 35%) due to catheter misplacement outside of the intended epidural space.

Significant research shows that spinal ultrasound guidance, compared to blind palpation, reduces the number of needle sticks required thereby significantly improving procedure efficacy and patient safety. While conventional ultrasound interpretation is beyond the typical provider’s skillset, Accuro’s automation enables anesthesia providers with little or no ultrasound experience to benefit from the modality.

The second generation Accuro also introduces a range of performance enhancements, including an advanced bone-specific ultrasound probe, optimized for improved bone imaging, and a wider field-of-view to expand ease-of-use. The new device also incorporates an optimized ergonomic design and added power-savings features.

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“Accuro has been selling in the global market for several years; customer success and clinical evidence collected worldwide have informed Accuro’s second generation optimization and the product line’s natural evolution,” comments Will Mauldin, PhD, co-founder and CEO of RIVANNA, the device manufacturer and marketer. “The new Thoracic presetting and Accuro Locator needle guide were inspired by customer demand. We listened to providers and delivered an Accuro with the performance to maximize the efficiency of real-time image guidance.”

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Development of Accuro’s new technologies for thoracic epidural placement and validation through clinical study were sponsored by the National Institute of General Medical Sciences of the National Institutes of Health. This included review of more than 50,000 images collected at Memorial Sloan Kettering Hospital under principal investigator Amitabh Gulati, which were rigorously tested, optimized and integrated into the Accuro’s new thoracic preset.