Canadian Enrollment Begins in B-SILENT Study of Sonorous’s BosStent Cerebral Venous Stent

September 2, 2026—Sonorous Neurovascular announced the commencement of enrollment at Canadian sites in the B-SILENT clinical study of the company’s investigational BosStent. The braided, self-expanding cerebral venous stent is being evaluated for the treatment of patients with debilitating pulsatile tinnitus associated with symptomatic cerebral venous sinus stenosis.

According to Sonorous, the international B-SILENT study is designed to generate essential safety and performance data to support a future submission for CE Mark approval for BosStent device in Europe. In France, four clinical sites have been participating in the study.

In Canada, B-SILENT is being conducted at The Ottawa Hospital in Ottawa and St. Michael’s Hospital in Toronto.

On August 3, the company announced that the first patient was enrolled at The Ottawa Hospital by Robert Fahed, MD.

“As Principal Investigator for the B-SILENT study at The Ottawa Hospital, I’m encouraged by the successful enrollment of our first patient,” commented Dr. Fahed in the Sonorous press release from August 3. “Pulsatile tinnitus can be a debilitating and often under-recognized condition, and studies like B-SILENT are important steps toward giving physicians new tools to help patients who have limited options today. I look forward to our site’s continued contribution to this study.”

The first patient enrollment at St. Michael’s Hospital was announced on September 1. At St. Michael’s, the study is being led by neurosurgeon Vitor Mendes Pereira, MD, who is Director of Endovascular Research and Innovation, and being coordinated by The RADIS Lab, noted the company.

“Pulsatile tinnitus can be extremely debilitating, yet patients often spend years searching for an explanation and an effective treatment,” stated Dr. Pereira in the press release from September 1. “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.”

In the United States, the FDA has granted Breakthrough Device designation for the BosStent, which the company announced in February 2026.