VS3 Medical Announces First Patients Enrolled in First-in-Human Study of Novel Neurovascular Implant to Address Symptomatic Venous Sinus Stenosis

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SAN JOSE, Calif.--(BUSINESS WIRE)--Mar 9, 2026--

VS3 Medical, Inc., a private company developing novel neurovascular implants, today announced it has commenced enrollment in its international first-in-human (FIH) study evaluating its VS3 Medical™ Stent System for patients with symptomatic venous sinus stenosis. Symptomatic venous sinus stenosis is characterized by narrowing of the brain’s main drainage veins. The first cases enrolled were presented at the 2026 Society of Neuroinventional Surgery (SNIS) Cerebral Venous and CSF Disorders Summit, held March 5-7, 2026, in Colorado Springs, Colo.

The investigational VS3 Medical Stent System was developed to specifically address the unique properties of venous sinus anatomy and stenoses. The FIH study is a prospective, multi-center feasibility study with enrolling sites in Canada and Australia. The study is designed to evaluate primary outcomes of safety, efficacy and performance at three-months post-index procedure. The study employs both an independent core lab and a data safety monitoring board. Immediately following the planned procedures for venous sinus stenting with the VS3 Medical Stent System, all patients had resolution of their debilitating pulsatile tinnitus symptoms. All patients were discharged neurologically intact within 24 hours of the procedures.

“The VS3 Medical Stent System is a potential breakthrough for patients suffering from debilitating pulsatile tinnitus,” said Dr. Robert Fahed, FIH study investigator and interventional neuroradiologist and stroke neurologist at The Ottawa Hospital in Ottawa, Ontario, 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.”

“Patients who suffer from symptomatic venous sinus stenosis often struggle for years before they are appropriately identified,” said Dr. Matthew Amans, interventional neuroradiologist and founder of VS3 Medical. “We have developed a device that is designed specifically to address the unique anatomy and hemodynamics of their condition.”

“I am thrilled to be a part of the VS3 team as we work to advance this important technology and generate meaningful clinical evidence,” said Thomas C. Wilder, chief executive officer of VS3 Medical. “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.”

About Symptomatic Venous Sinus Stenosis

Symptomatic venous sinus stenosis occurs in the venous vasculature of the brain and is characterized by narrowing of the brain’s main drainage veins. Patients with venous sinus stenosis may present with symptoms of debilitating pulsatile tinnitus or papilledema and headaches related to idiopathic intracranial hypertension (IIH). Debilitating pulsatile tinnitus typically presents as pulse-synchronous rhythmic “whooshing” sound in one or both ears. Papilledema, or optic disc swelling, affects vision due to swelling of the optic nerve head caused by increased pressure in the head.

About VS3 Medical, Inc.

VS3 Medical is a privately held medical device company focused on delivering optimized solutions to address symptomatic venous sinus stenosis and overcome the unique challenges of the dural venous sinus anatomy. The company’s VS3 Medical Stent System is an investigational device and is not available for sale. Founded in 2022, VS3 Medical is funded by premier medical investors U.S. Venture Partners, Santé Ventures, Gilde Healthcare and Aperture Venture Partners. For more information, please visit www.vs3medical.com and follow VS3 Medical on LinkedIn.

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SOURCE: VS3 Medical

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PUB: 03/09/2026 09:00 AM/DISC: 03/09/2026 09:00 AM

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