InTRAvent wins FDA 510(k) clearance for Solopass bedside neuro-navigation device

InTRAvent has announced FDA 510(k) clearance of its Solopass system for assisting frontal placement of intraventricular catheters deep within the brain.

The Hershey, Pennsylvania-based company said yesterday that it designed the device with 2D and 3D ultrasound imaging, artificial intelligence and trajectory guidance for intraprocedural localization and navigation for external ventricular drain (EVD) placement.

“Early on in my career, I lost a patient I was caring for as a result of EVD complications,” inTRAvent co-founder and Chief Medical Officer Dr. Will Hazard said in a news release. “Our aim has always been to advance the standard of care for this all-too-common, unsolved problem.”

EVD placements are among the most common life-saving procedures in neurointensive care, the company said, but although neuro-navigation is routinely used in neurosurgical operating rooms, bedside EVD catheter procedures in the ICU and ER rely on surface landmarks and the physician’s experience with and knowledge of the brain’s anatomy. Bedside EVD placement can be especially challenging when the intricate intracranial anatomy is distorted (known as “brain shift”) due to excess cerebrospinal fluid, traumatic brain injury, cerebral edema or other conditions that dangerously increase pressure in the skull.

“Solopass represents a significant advancement in the treatment of these critically ill patients, and we believe it can potentially reduce downstream healthcare costs associated with lengthy stays in the ICU,” inTRAvent co-founder and CEO Adam Barner said in the news release.

Original Article: (https://www.medicaltubingandextrusion.com/intravent-solopass-fda-510k-clearance-bedside-neuro-navigation-evd/)