VS3 Medical has announced it has commenced enrolment in its international first-in-human (FIH) study evaluating the VS3 Medical stent system for patients with symptomatic venous sinus stenosis. The first enrolled cases were presented at the 2026 Society of NeuroInventional Surgery (SNIS) Cerebral Venous and Cerebrospinal Fluid (CSF) Disorders Summit (5–7 March, Colorado Springs, USA).
“Patients who suffer from symptomatic venous sinus stenosis often struggle for years before they are appropriately identified,” said VS3 Medical founder Matthew Amans (University of California San Francisco [UCSF], San Francisco, USA). “We have developed a device that is designed specifically to address the unique anatomy and haemodynamics of their condition.”
VS3 Medical’s FIH study is a prospective, multicentre feasibility study with enrolling sites in Canada and Australia. It has been designed to evaluate primary outcomes of safety, efficacy and performance at three months post-index procedure, and is employing an independent core lab as well as a data safety monitoring board.
Immediately following the planned procedures for venous sinus stenting (VSS) with the VS3 Medical system, all patients had resolution of their debilitating pulsatile tinnitus symptoms. Additionally, all patients were discharged neurologically intact within 24 hours of the procedures, according to VS3 Medical.
“The VS3 Medical stent system is a potential breakthrough for patients suffering from debilitating pulsatile tinnitus,” commented FIH study investigator Robert Fahed (The Ottawa Hospital, Ottawa, Canada). “The VS3 Medical stent was easily deployed with high precision from the torcula to the sigmoid sinus, and conformed without distorting the anatomy. In the future, this new technology may simplify what is traditionally a complex procedure fraught with technical difficulty, eliminating the need for multiple stents and angioplasty after stenting.”
“I am thrilled to be a part of the VS3 team as we work to advance this important technology and generate meaningful clinical evidence,” added VS3 Medical chief executive officer (CEO) Thomas Wilder. “We are committed to executing a multi-year strategy, involving a series of prospective clinical studies, aimed at demonstrating the safety and clinical utility of the purpose-built VS3 Medical stent system for this important patient population.”
