BLUE BELL, PA — inTRAvent Medical Partners LP has completed the first patient procedure using its SOLOPASS 2.0 ultrasound-guided neuronavigation system in a clinical trial at Penn State Health Milton S. Hershey Medical Center, advancing efforts to improve the accuracy of brain catheter placement during emergency and bedside neurosurgical procedures.
The September 22 procedure marks the first clinical use of the company’s FDA-cleared system in an investigator-initiated study evaluating ultrasound-guided external ventricular catheter placement.
The trial is led by Chris Zacko, MD, of Penn State Health’s Department of Neurosurgery and Penn State College of Medicine.
External ventricular catheters are used to drain cerebrospinal fluid from the brain, including in patients with conditions that cause dangerous increases in intracranial pressure. Accurate placement is important because unsuccessful attempts can require repeated insertion.
Conventional freehand placement relies on anatomical landmarks, while other navigation methods use preoperative CT or MRI scans and registration procedures to guide catheter insertion.
SOLOPASS 2.0 instead uses real-time ultrasound imaging and navigation during the procedure, allowing clinicians to account for changes in brain position and anatomy.
“Freehand ventricular catheter placement is widely described in the literature as inaccurate, and every missed or repeated pass adds risk for our patients,” Zacko said. “We believe real-time ultrasound imaging and navigation will improve placement accuracy and safety, and this study is designed to measure that.”
The trial will assess catheter placement accuracy in patients, following preclinical research that found the system significantly more accurate than freehand placement.
Kevin Foley, MD, inTRAvent’s chief innovation officer, said the earlier study, published in Neurosurgery, demonstrated consistent accuracy improvements regardless of operator experience.
“This trial is the next step in understanding how that translates to patients,” Foley said.
The clinical evaluation represents a transition from preclinical testing to human use for the Blue Bell-based medical device company.
SOLOPASS 2.0 is designed as a platform for image-guided neurosurgery, initially targeting ventricular catheter placement in operating rooms and at the bedside.
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