Charlottesville,
VA, USA -- A clinical trial conducted at Stanford University
Medical Center published this week in Anesthesia & Analgesia*
proved the accuracy of the Accuro® image-guided spinal navigation
system in calculating the optimal site and needle depth for epidural
anesthesia administration. The research is the latest in a series of
studies supporting the efficacy of RIVANNA's
handheld ultrasound system with proprietary pattern recognition
software, which identifies spinal landmarks and provides automated
epidural placement guidance. The innovative Accuro platform also has
application in a range of additional medical procedures that benefit
from visualization of targeted anatomical areas.
In
the trial, RIVANNA® Accuro identified the appropriate epidural
injection sites along the lower spine and calculated the depth to the
epidural space, a narrow hollow area in the spine. Actual epidural
depth was confirmed by measuring needle penetration during successful
epidural delivery by anesthesia providers. Accuro predicted this
depth within an average of .61 cm.
In
addition, Accuro identified the appropriate spinal interspace for
needle insertion in 94% of patients and enabled 87% success in
first-attempt epidural administration. The research was conducted
under the direction of Brendan Carvalho, MD, at Stanford Medical
Center and led by Katherine Seligman, MD, currently faculty at the
University of New Mexico.
"The
ability to visualize spinal anatomy in detail during epidural needle
placement has a strong impact on the procedure's success," says
Will Mauldin, Chairman and CEO of Rivanna
Medical. "Today, anesthesiologists rely on
spinal palpation and their knowledge of spinal anatomy to determine
the appropriate injection site and depth. Depending on the patient
condition and physician skill, up to 80% of first attempt epidural
needle placements fail. Obesity and atypical spinal characteristics
such as scoliosis place patients significantly at failure risk."
Repeated
epidural needle insertions can negatively impact the patient with
ongoing headaches, bleeding, back pain and possibly paralysis. Failed
epidurals cost the medical system more than $1.5 billion annually.
Mauldin
notes that ultrasound is the imaging modality of choice for epidurals
because most are administered to expectant mothers who must avoid the
radiation involved in other imaging procedures.
Significant
research shows that ultrasound guidance of epidural and other
neuraxial anesthesia significantly improves efficacy and patient
safety. However, performing and interpreting ultrasound requires
specialized training not typically in the anesthesia provider's
skillset.
Accuro's
SpineNav3D™ computerized ultrasound image guidance eliminates the
steep ultrasound learning curve, making it simple and practical for
anesthesiologists and other medical professionals not trained in the
modality.
"This
study published in a respected anesthesiology publication underscores
the device's precision in providing physician guidance," says
Mauldin.
In
addition to innovative image guidance, RIVANNA Accuro also
incorporates BoneEnhance® technology, which optimizes the device for
visualization of bony spinal anatomy. Accuro delivers a five- to
10-fold increase in bone-to-tissue contrast compared to traditional
ultrasound, which is generally preferred for soft tissue imaging. The
pocket-sized, wireless device is simple and practical to use in a
wide range of settings where traditional large, unwieldy systems can
be a problem.
"Accuro
is designed to eliminate the risks of multiple needle placement
attempts, increasing patient satisfaction while supporting
anesthesiology workflow," notes Mauldin. "A growing number
of studies underscore the device's success in meeting these goals."
A
recent randomized trial at University of Virginia Medical Center
found that for residents with prior spinal anesthesia experience,
Accuro improved first-attempt needle placement by more than 100% in
patients with a high body mass index. Appropriate needle placement in
these patients is particularly difficult. The average number of
needle redirections to achieve placement using Accuro was almost half
that of the same sub-group using conventional placement methods.
*
ANESTHESIA & ANALGESIA is the official journal of the
International
Anesthesia Research Society.
About
Accuro® and Rivanna Medical, LLC
RIVANNA®
Accuro is the world's first ultrasound-guidance system designed to
effortlessly enhance spinal and epidural anesthesia placement
accuracy. The revolutionary platform features BoneEnhance®, which
optimizes ultrasound for the visualization of bony vs. soft tissue
anatomy, and SpineNav3D™, which automates measurements of the
spinal midline, epidural depth and trajectory. Accuro was engineered
and commercialized by RIVANNA, an innovative medical device company
headquartered in Charlottesville, VA. The proprietary device is FDA
510(k)-cleared for a variety of imaging applications. For anesthesia
providers, certainty can be effortless with Accuro. For more
information, visit http://www.rivannamedical.com.
Copyright
© by Rivanna Medical, LLC. All rights reserved. RIVANNA® and
Accuro® are registered trademarks of Rivanna Medical, LLC.
Media
Contact:
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Jeanne-Marie
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