CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--Rivanna Medical announced today that it has begun selling its Accuro device to anesthesia providers as a result of a successful product launch at the annual meeting of the American Society of Anesthesiologists (ASA) in San Diego last week. The company also announced that it is continuing discussions with three potential corporate partners.
Accuro’s initial commercial application is designed to provide 3D navigation of the lumbar spine to automatically guide clinicians to a first-attempt success in administering spinal and epidural anesthesia.
“Anesthesia providers attending the recent ASA scientific meeting told us that Accuro fulfills a significant unmet clinical need for automated image guidance,” said John A. Williams, President and CEO, “especially in the spinal anesthesia sector.”
Williams explained that needle insertion for spinal and epidural anesthesia is a demanding procedure, especially for inexperienced physicians in general, and in particular in patients with high-BMI.
“Knowing the variable configuration of an individual’s lumbar anatomy for a specific patient is essential to predicting the appropriate puncture site, needle trajectory, and depth of needle insertion to reach the epidural space, “ Williams said. “But without medical imaging, the physician is left to guesswork.”
Before inserting the needle, ‘blind’ palpation of spinal bone anatomy is usually used to substantiate at what angle and location to insert the epidural needle. In other words, the physician makes an informed estimate at where, and how deep, to place the epidural needle. “But what if the provider’s estimate is wrong?“ asked Williams.
The epidural space in an average adult is only about 10 mm in diameter and 5 mm in thickness, a difficult volume to hit with blind insertion. If the needle misses this narrow target, it can puncture the outermost membrane enveloping the spine. This may cause cerebrospinal fluid (CSF) to leak into the epidural space, which leads to a “spinal headache” that ranges from mild to debilitating.
On the other hand, the Accuro imaging device provides automatic identification of epidural location and depth. And, Accuro is designed so the anesthesia provider can carry it in his or her pocket.
Data from a recently completed clinical study at the University of Virginia School of Medicine showed that Rivanna Medical’s Accuro device was 94% successful in automatically identifying the epidural space via its proprietary real-time 3D image automation technology, SpineNav3D™. The study’s principal investigator was Mohamed Tiouririne, MD, Dept. of Anesthesiology, University of Virginia School of Medicine.
Rivanna Medical has received FDA 510(k) clearance to market Accuro, a handheld and untethered smart phone-sized device that is designed to guide neuraxial anesthesia and perform diagnostic imaging of the musculoskeletal and abdominal anatomies.
Based in Charlottesville, Virginia, RIVANNA is a privately held medical technology company that is commercializing its initial product, Accuro™, a proprietary and versatile imaging product that is FDA 510(k)-cleared for spinal anesthesia guidance and a variety of additional imaging applications, such as diagnostic imaging of the cardiac and abdominal anatomies.