First-in-human procedure completed in a study of ultrasound-guided external ventricular catheter placement led by Chris Zacko, MD

BLUE BELL, Pa.: inTRAvent Medical Partners LP, a medical device company dedicated to bringing intra-operative imaging and navigation to the bedside, today announced that the first patient has been successfully treated with its FDA-cleared SOLOPASS® 2.0 ultrasound-guided bedside neuronavigation system in an investigator-initiated clinical trial at Penn State Health Milton S. Hershey Medical Center. The first-in-human procedure was performed Sept. 22.

The study, Ultrasound (US) Guided External Ventricular Catheter Placement, is led by principal investigator Chris Zacko, MD, of the Department of Neurosurgery at Penn State Health and Penn State College of Medicine, and is evaluating the accuracy of ventricular catheter placement using SOLOPASS® 2.0.

“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.”

Traditional navigation depends on preoperative CT or MRI and complex registration, which can delay treatment when a critically ill patient must be moved for imaging. SOLOPASS® 2.0 instead provides real-time ultrasound imaging and navigation during the procedure, accounting for brain shift and changing pathology. It is built as a platform for image-guided neurosurgery, beginning with ventricular access in the operating room and at the bedside.

“Moving from simulated use to clinical use is the milestone that matters,” said Kevin Foley, MD, inTRAvent’s Chief Innovation Officer. “Our preclinical study published in Neurosurgery showed SOLOPASS® 2.0 was significantly more accurate than freehand placement, with consistent results regardless of experience. This trial is the next step in understanding how that translates to patients.”

About inTRAvent Medical Partners

inTRAvent Medical Partners is a medical device company dedicated to bringing intra-operative imaging and navigation to the bedside to improve the safety and efficacy of neurosurgical procedures. The Company’s FDA Cleared SOLOPASS® platform enables simple, portable neuro-navigation using 2D and 3D ultrasound imaging, artificial intelligence, and trajectory guidance for intra-procedural localization and navigation. For more information, please visit www.inTRAventMedical.com, or find us on LinkedIn.

Fonte: Business Wire