Study Begins for Neurovascular Implant That Treats Symptomatic Venous Sinus Stenosis

VS3 Medical Inc. has started enrolling subjects in its international first-in-human (FIH) study evaluating the VS3 Medical Stent System for patients with symptomatic venous sinus stenosis, a condition characterized by narrowing of the brain’s main drainage veins.

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

The investigational VS3 Medical Stent System was developed to specifically address the properties of venous sinus anatomy and stenoses. The FIH study is a prospective, multi-center feasibility trial with enrolling sites in Canada and Australia that is evaluating the safety, efficacy, and performance of the VS3 System three-months after the procedure. The study employs both an independent core lab and a data safety monitoring board. Immediately after the venous sinus stenting procedures using the VS3 Medical Stent System, all patients reported their pulsatile tinnitus symptoms disappeared. Additionally, 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,” stated 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.”

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

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

VS3 Medical is a privately held medical device company developing 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.