BLUE BELL, PA — inTRAvent Medical Partners LP announced that its SOLOPASS® 2.0 navigation system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), advancing its platform for real-time ultrasound imaging during external ventricular drain (EVD) placement.
Building on the foundation of the original SOLOPASS® system, the upgraded 2.0 version introduces faster processing speeds, a more intuitive workflow, and an improved fixation mechanism to simplify setup. The enhancements are designed to reduce procedure time, improve accuracy, and better support clinicians in critical-care and time-sensitive environments.
SOLOPASS® 2.0 combines frameless fixation with live anatomical imaging, offering accurate localization and navigation without relying on preoperative scans. By providing real-time visualization, the system addresses challenges posed by brain shift — a key limitation in conventional navigation platforms — and reduces risks for patients with cerebral edema or evolving intracranial pathology.
“Image-guided navigation is common in the OR, but current systems relying on preoperative imaging and complex registration are not conducive to treating emergent bedside cases,” said Dr. Kevin Foley, inTRAvent’s chief innovation officer. “SOLOPASS® 2.0 bridges this gap by bringing real-time, accurate navigation directly to the patient’s bedside, which I believe will transform how we manage the treatment of critically ill patients.”
“This clearance, combined with our strengthened leadership team, positions us to deliver a transformative bedside navigation solution that raises the standard of care in neuro-critical settings,” added Adam Barner, CEO of inTRAvent. “With SOLOPASS® 2.0, we are not only evolving the technology — we are elevating patient outcomes and clinician confidence.”
The FDA clearance marks a significant milestone for inTRAvent as it looks to expand adoption of its navigation solutions in neuro-critical care settings, where speed and precision are essential.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.