FDA Grants Breakthrough Designation to Sonorous Neurovascular for Cerebral Venous Stent

Sonorous Neurovascular has earned U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its braided, self-expanding BosSTENT.

Symptomatic venous sinus stenosis is a primary contributor to debilitating pulsatile (pulse-synchronous) tinnitus. Current treatment options remain limited for many patients. The purpose-built BosSTENT delivers an optimized solution through its proprietary design—featuring optimal radiopacity, enhanced visibility, resheathability for precise deployment, and excellent conformability in complex anatomy, according to the company.

“This FDA Breakthrough Device Designation is a major milestone for Sonorous Neurovascular and, most importantly, for the patients suffering from debilitating pulsatile tinnitus,” Sonorous Neurovascular President Joel Harris said. “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. We are grateful for the FDA’s recognition and look forward to collaborating closely under this program to accelerate access to treating patients.”

The designation follows promising early clinical experience, including first-in-human uses and ongoing studies evaluating BosSTENT’s safety and performance in treating pulse-synchronous tinnitus and other venous sinus stenosis symptoms.

The FDA’s Breakthrough Devices Program aims to provide patients and healthcare providers with more timely access to innovative medical devices that potentially can provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Sonorous Neurovascular is advancing clinical trials and regulatory pathways to bring the BosSTENT to patients in the United States and beyond.

Pulsatile (pulse-synchronous) tinnitus is a form of tinnitus characterized by a rhythmic whooshing, thumping, or pulsing sound in one or both ears that synchronizes with the individual’s heartbeat. The condition often stems from identifiable vascular or circulatory issues, such as turbulent blood flow near the ear caused by cerebral venous sinus abnormalities.

Sonorous Neurovascular is a clinical-stage medical device company developing solutions for cerebral venous diseases. The company’s flagship BosSTENT is designed to address symptomatic cerebral venous sinus stenosis, offering hope to patients with debilitating pulsatile tinnitus. Headquartered in Lake Forest, Calif., Sonorous Neurovascular improves patient outcomes through minimally invasive technologies and diagnostics.