Breakthrough Status for Sonorous BosSTENT for Pulsatile Tinnitus

FDA has granted Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral venous stent designed to treat debilitating pulsatile tinnitus. BosSTENT is a braided, self-expanding venous stent designed to treat symptomatic cerebral venous sinus stenosis, a condition widely recognized as a major contributor to pulse-synchronous tinnitus, according to the company. Pulsatile tinnitus is characterized by rhythmic sounds that align with a patient’s heartbeat and can significantly impair quality of life.

Sonorous says BosSTENT was purpose-built for venous anatomy and includes features such as enhanced radiopacity, improved visibility during placement, resheathability, and conformability in complex cerebral vessels. Current treatment options for venous sinus stenosis remain limited, and many procedures are performed off-label using arterial stents, it adds.