В канадской больнице завербирован первый пациент в международном исследовании стента для лечения пульсирующего шума

International B-SILENT Study of Venous Stenting for Pulsatile Tinnitus Enrolls First Patient in Toronto Hospital LAKE FOREST, Calif., Sept. 1, 2026 /PRNewswire/ -- Sonorous Neurovascular, a medical device company focused on cerebral venous diseases and neurovascular interventions, today announced that it has enrolled its first patient at a Toronto hospital in B-SILENT (NCT07070089), an international clinical study evaluating an investigational cerebral venous stent for patients with debilitating pulsatile tinnitus associated with symptomatic cerebral venous sinus stenosis. The clinical evaluation is being led by Dr. Vitor Mendes Pereira, neurosurgeon and Director of Endovascular Research and Innovation at St. Michael's Hospital in Toronto, Canada. The B-SILENT study is evaluating the investigational use of BosSTENT™, Sonorous' braided, self-expanding cerebral venous stent, for the treatment of debilitating pulsatile tinnitus caused by symptomatic cerebral venous sinus stenosis. The study is designed to generate essential safety and performance data to support a future CE Mark submission. St. Michael's and The Ottawa Hospital are Canadian sites in B-SILENT, extending the study's international enrollment beyond France, where four clinical sites are participating. The collaboration across French and Canadian centers reflects growing clinical interest in generating rigorous evidence for the treatment of pulsatile tinnitus associated with cerebral venous sinus stenosis. At St. Michael's, B-SILENT is coordinated through the RADIS Lab, with Eileen Liu and Alphonse Potvin providing clinical support for the study. "The expansion of B-SILENT into Canada is an important step for the study and for patients living with debilitating pulsatile tinnitus," said Joel Harris, CEO of Sonorous Neurovascular. "We are grateful to Dr. Pereira and the St. Michael's team, Dr. Fahed and the team at The Ottawa Hospital, and our colleagues across France for their commitment to advancing this research. Their collaboration is essential to building the clinical evidence needed to evaluate this investigational therapy." "Pulsatile tinnitus can be extremely debilitating, yet patients often spend years searching for an explanation and an effective treatment. In appropriately selected patients, venous sinus stenosis can be an important underlying cause. B-SILENT gives us the opportunity to rigorously evaluate a technology specifically designed for the cerebral venous system and, ultimately, to build the evidence needed to improve how we treat these patients," said Dr. Pereira. Sonorous Neurovascular continues to progress its clinical programs across both U.S. and international regulatory pathways, building on the company's FDA Breakthrough Device Designation for BosSTENT™ and 510(k) clearance for BosCATH™. These achievements support Sonorous' mission of improving the lives of patients affected by pulsatile tinnitus and other venous outflow disorders through minimally invasive, purpose-built therapies. About Sonorous Neurovascular Sonorous Neurovascular is a clinical-stage medical device company headquartered in Lake Forest, California, dedicated to developing transformative technologies for the treatment of cerebral venous diseases. The company's innovative portfolio, including the BosSTENT™ (recently granted FDA Breakthrough Device Designation) and BosCATH™, aims to provide safe, effective, and purpose-built solutions that improve patient outcomes. Sonorous is actively advancing international clinical research, including the B-SILENT study (NCT07070089) evaluating the investigational use of BosSTENT™ for debilitating pulsatile tinnitus at sites in France and Canada to support CE Mark submission. For more information, visit www.sonorousnv.com. Contact: James D. Nonato, Vice President Sonorous Neurovascular Email: [email protected] Phone: +1 (888) 830 1445 SOURCE Sonorous Neurovascular