Intravent Medical has announced that its next-generation navigation system, Solopass 2.0, has received 510(k) clearance from the US Food and Drug Administration (FDA).
Building upon the foundation established by the original, US FDA-cleared Solopass platform for real-time ultrasound imaging during external ventricular drain (EVD) placement, the latest system offers notable advancements to better serve clinical needs, according to Intravent. The updated system features faster processing speeds and a more intuitive workflow, streamlining operation for healthcare providers of all skill levels, the company adds in a recent press release.
The Solopass 2.0 system is also said to offer an improved fixation mechanism designed to make setup simpler and easier. These features—which aim to reduce time and improve accuracy during elective procedures—are particularly valuable in time-sensitive, critical-care environments, Intravent claims.
The enhanced system combines frameless fixation with image guidance for accurate localisation and navigation. According to Intravent, unlike other navigation systems that rely on preoperative imaging, Solopass 2.0 reduces the risk of errors caused by brain shift by providing live anatomical visualisation during both elective and emergency procedures, which reduces the risk of complications that can occur in patients with cerebral oedema or evolving intracranial pathology.
“Image-guided navigation is common in the OR [operating room], but current systems relying on preoperative imaging and complex registration are not conducive to treating emergent bedside cases,” said 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 neurocritical settings,” added Adam Barner, the company’s chief executive officer (CEO). “With Solopass 2.0, we are not only evolving the technology—we are elevating patient outcomes and clinician confidence.”
