Rivanna Medical said today it won Health Canada approval for its Accuro automatic spinal navigation system for epidural and neuroaxial anesthesia guidance.
The Accuro system is a pocket-sized, portable ultrasound guidance device which provides 3D navigation for needle insertions to improve clinician accuracy in placement, the Charlottesville, Va.-based company said.
“Accurate needle placement for epidural and related spinal anesthesia is challenging because physicians are essentially working blind and making assumptions about a patient’s spinal anatomy. If incorrect, repeated needle sticks often result in decreased patient satisfaction and quality scores. They also increase costs by prolonging anesthesia procedures and any operating room time involved. Moreover, serious complications due to spinal anesthesia failure cost the healthcare system more than $1.5 billion annually,” Rivanna CEO & chair Will Mauldin said in a press release.
Rivanna launched the device in the US in November 2015, alongside data from a clinical study of the device reported a 94% rate of success in identifying epidural space through its 3D image automation technology.
“A large body of research underscores the benefits of ultrasound for neuraxial anesthesia guidance. Now for the first time, Rivanna Accuro makes this practical, cost-effective and safe even for expectant mothers, who cannot be exposed to the radiation involved in other imaging procedures,” Rivanna clinical R&D director Adam Dixon said in a prepared statement.
The company said that it hopes to launch the device in Canada in May, and that it will be sold through a network of specialized distribution partners in the region