FDA approved an investigational device exemption for Sonorous Neurovascular's BosSTENT on October 2. The Lake Forest, California company announced it on October 7. B-SILENT 2 is the first US trial of a venous sinus stent for pulsatile tinnitus, and enrollment is expected to start in the fourth quarter.
BosSTENT is a braided self-expanding stent built for the cerebral venous sinuses, where a narrowed transverse or sigmoid sinus is the most common cause of the pulsing patients hear. Emanuele Orru of Lahey Hospital and Medical Center and Omar Choudhri of University of Chicago Medicine AdventHealth are co-principal investigators. A separate study, B-SILENT (NCT07070089), is enrolling at more than six sites in France and Canada toward a CE mark.
This is the company's third FDA milestone in eight months, after a Breakthrough designation in February and a 510(k) for the BosCATH support catheter (K254046) in April. Clearing the delivery catheter first is the useful part of the sequence: the tool reaches the market on a predicate while the implant that needs trial data follows behind it.