#Canada #Toronto #Sonorous Neurovascular #Pulsatile Tinnitus #BosSTENT

International B-SILENT Study Launches in Toronto

On September 1, 2026, Sonorous Neurovascular, a forward-thinking medical device company specializing in cerebral venous disorders and neurovascular interventions, announced a significant milestone in its research efforts by enrolling its first patient in Toronto as part of the B-SILENT study. This groundbreaking international clinical study aims to assess an investigational cerebral venous stent designed specifically for patients experiencing debilitating pulsatile tinnitus due to symptomatic cerebral venous sinus stenosis. The first enrollment occurred at St. Michael's Hospital, where Dr. Vitor Mendes Pereira, a neurosurgeon and the Director of Endovascular Research and Innovation, is spearheading the clinical evaluation.

The B-SILENT study focuses on the use of BosSTENT™, Sonorous’ self-expanding braided cerebral venous stent. This innovative device is intended to alleviate symptoms of pulsatile tinnitus through a minimally invasive procedure while supporting the collection of crucial safety and performance data. This data is essential for future submissions for regulatory approvals, including CE Mark certification.

St. Michael's Hospital is joined by The Ottawa Hospital as the first Canadian sites to contribute to the B-SILENT study, expanding its international scope which initially included four clinical sites in France. This collaboration underscores the growing clinical interest in improving treatment methods for pulsatile tinnitus, particularly those linked to cerebral venous sinus stenosis.

Expert Insights on the Study

Dr. Vitor Mendes Pereira stated, “The expansion of the B-SILENT study into Canada marks an essential step forward both for the research itself and for patients living with the challenges of pulsatile tinnitus.” Joel Harris, the CEO of Sonorous Neurovascular, emphasized the dedication of medical teams at St. Michael's and The Ottawa Hospital, along with their counterparts in France. Harris lauded their collaborative efforts as pivotal in honing the clinical evidence necessary for evaluating this innovative therapy.

Pulsatile tinnitus is often a perplexing condition for affected individuals, with many enduring years of discomfort while searching for explanations and effective treatments. Dr. Pereira remarked, “In appropriately selected patients, venous sinus stenosis can serve as a fundamental cause. The B-SILENT study provides us with an opportunity to systematically evaluate a specialized technology tailored for the cerebral venous system. Our ultimate goal is to accumulate substantial evidence that will refine our therapeutic approaches for these patients.”

Future Directions for Sonorous Neurovascular

Sonorous Neurovascular continues to advance its clinical programs, both in the United States and abroad, building upon its accolades, including the FDA Breakthrough Device Designation for the BosSTENT™ and the 510(k) clearance for the BosCATH™. These accomplishments reinforce the company's vision of enhancing the quality of life for patients impacted by pulsatile tinnitus and other venous outflow disorders through innovative and purpose-built therapeutic interventions.

Founded in Lake Forest, California, Sonorous Neurovascular is committed to developing transformative solutions for cerebral venous diseases. Their product portfolio not only aims to provide safe and effective treatments but also focuses on improving patient outcomes significantly. The B-SILENT study (NCT07070089) reflects the company's ongoing commitment to advancing clinical research in partnership with multiple sites in France and Canada.

For more information about Sonorous Neurovascular and the B-SILENT study, please visit www.sonorousnv.com.