PALM BEACH GARDENS, Fla., Nov. 03, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical expertise firm targeted on accelerating the adoption of minimally invasive surgical procedure (MIS) as the usual of care in spine, right now introduced that the U.S. Food & Drug Administration (FDA) had cleared Accelus’s 510(okay) software for its Remi™ Robotic Navigation System software program replace that enables picture seize with the GE OEC 3D, Ziehm Imaginative and prescient RFD 3D, and Stryker Airo TruCT techniques.
The Remi Robotic Navigation System is a robotic focusing on and navigation platform that gives robotic-assisted pedicle screw placement for surgeons performing lumbar spine fixation. It was cleared by the FDA in February 2021 with affected person anatomy and fiducials recognized via an O-arm scan. The brand new FDA clearance permits the system for use with a broader portfolio of 3D imaging techniques, which might scale back the obstacles typically related to robotic navigation.
“Value, footprint and complexity have been beforehand unscalable obstacles that stored robotic spine surgical procedure from being carried out wherever however at massive hospitals; nonetheless, the Remi system’s new clearance offers smaller amenities and ambulatory surgical procedure facilities (ASCs) with entry to its disruptive expertise that may assist exactly navigate for correct screw placement with decreased reliance on conventional fluoroscopy,” Chris Walsh, Accelus’s Chief Government Officer and Co-Founder, mentioned. “We’re proud to have achieved this subsequent step as we glance to fulfilling the remaining unmet wants in spinal robotic navigation and are excited to now be capable of supply our Remi Robotic Navigation System to so many extra amenities and surgeons.”
The Remi system was designed to deal with the inherent limitations of legacy robotic techniques in spine, together with prolonged setup and teardown time, excessive prices, procedural workflow disruptions and taking over a big footprint within the working room (O.R.). This new clearance enhances the benefits of the Remi system by permitting it for use with a large number of 3D imaging techniques, lessening the necessity for hospitals to spend money on a particular imaging platform.
“The Remi system addresses the considerations of earlier spinal navigation techniques with equal accuracy and an optimized procedural workflow at a fraction of the fee. The flexibility to mix it with the GE OEC 3D system is game-changing for my observe,” mentioned Ernest Braxton, MD, MBA, neurosurgeon at Vail-Summit Orthopaedics and Neurosurgery. “Having the ability to make the most of robotic navigation in an ASC outpatient setting offers me with the precision I want with much less radiation publicity for my sufferers, my O.R. group, and me. It’s a win-win-win.”
All Remi Robotic Navigation Methods within the discipline can be up to date to the newly cleared software program and also will proceed to be appropriate to be used with O-arm imaging.
Accelus is dedicated to accelerating minimally invasive spine surgical procedure via its enabling expertise with broad accessibility to beforehand underserved markets. Established in 2021 via the mix of Integrity Implants and Fusion Robotics, the corporate is concentrated on offering its proprietary Adaptive Geometry™ expertise with pragmatic and economical navigation and robotic options with broad medical use in spine surgical procedure. Study extra at www.accelusinc.com.
GE, Ziehm and Stryker should not affiliated with Accelus and nothing on this press launch is meant to indicate a relationship with, or endorsement or sponsorship of Accelus or its merchandise by, these or another corporations.
Media Contact: Brandy Craig