Sonorous Neurovascular earns FDA breakthrough mark for novel stent

Sonorous Neurovascular received FDA breakthrough device designation for its BosSTENT device intended to treat pulsatile tinnitus, the company announced on Thursday.

“The BosSTENT represents years of focused innovation to deliver an on-label, minimally invasive solution that normalizes venous hemodynamics and has the potential to dramatically improve quality of life for individuals with pulsatile tinnitus.” Sonorous Neurovascular President Joel Harris said.

BosSTENT is a novel braided, self-expanding stent that differs from traditional mesh stents; and features optimal radiopacity, enhanced visibility and resheathability, according to the Lake Forest, California-based company.

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