FIH Study Begins for VS3 Medical Stent System for Symptomatic Venous Sinus Stenosis

March 9, 2026—VS3 Medical, Inc. announced it has commenced enrollment in an international first-in-human (FIH) study evaluating the VS3 Medical stent system for patients with symptomatic venous sinus stenosis. The investigational device was developed to address the unique properties of venous sinus anatomy and stenoses, noted the company.

Findings from the first patients enrolled in the study were presented at the Society of Neurointerventional Surgery’s 2026 Cerebral Venous and CSF Disorders Summit held March 5-7 in Colorado Springs, Colorado.

According to VS3, the prospective, multicenter feasibility study is enrolling patients at sites in Canada and Australia. The study is designed to evaluate primary outcomes of safety, efficacy, and performance of the VS3 stent system at 3 months after the index procedure. The study employs both an independent core lab and a data safety monitoring board, advised the company.

The company reported that immediately after the planned procedures for venous sinus stenting with the VS3 Medical stent system, all patients had resolution of their debilitating pulsatile tinnitus symptoms. Additionally, all patients were discharged neurologically intact within 24 hours of the procedures.

Robert Fahed, MD, an investigator in the FIH study and an interventional neuroradiologist and stroke neurologist at The Ottawa Hospital in Ottawa, Canada, commented on the device in the press release.

“The VS3 Medical stent system is a potential breakthrough for patients suffering from debilitating pulsatile tinnitus,” stated Dr. Fahed. “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.”