Sonorous Neurovascular has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its BosSTENT™ device, a new treatment for pulsatile (pulse-synchronous) tinnitus.
This designation is part of the FDA’s Breakthrough Devices Program, which aims to provide patients and healthcare professionals with faster access to innovative devices for serious or permanently debilitating conditions.
Pulsatile tinnitus is often caused by narrowing of the cerebral venous sinuses, leading to a rhythmic whooshing or thumping sound that matches the heartbeat.
The condition can severely affect daily life, and treatment options remain limited for many patients.
The BosSTENT™ is a purpose-designed, braided, self-expanding stent that improves blood flow in affected vessels. It features high visibility under imaging, the ability to be repositioned during placement, and flexibility to adapt to complex vascular anatomy.
Early clinical experience, including first-in-human procedures, has shown promising results in treating pulse-synchronous tinnitus and related symptoms.
Sonorous Neurovascular is continuing clinical trials and regulatory work to bring the BosSTENT™ to patients in the United States and internationally.
The device represents a minimally invasive solution that may help restore normal blood flow and improve quality of life for those affected by this challenging condition.
