--- title: "08:36 ETSonorous Neurovascular Receives FDA Breakthrough Device Designation for BosSTENT™, First Braided Self-Expanding Cerebral Venous Stent, to Treat Debilitating Pulsatile Tinnitus" type: "News" locale: "en" url: "https://longbridge.com/en/news/274983325.md" description: "Sonorous Neurovascular has received FDA Breakthrough Device Designation for its BosSTENT™, the first braided self-expanding cerebral venous stent aimed at treating debilitating pulsatile tinnitus. This designation is part of the FDA's initiative to expedite access to innovative medical devices for serious conditions. The BosSTENT™ features a proprietary design that enhances visibility and deployment precision, potentially improving the quality of life for patients. The company is advancing clinical trials to bring the device to market in the U.S. and beyond." datetime: "2026-02-05T13:37:16.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/274983325.md) - [en](https://longbridge.com/en/news/274983325.md) - [zh-HK](https://longbridge.com/zh-HK/news/274983325.md) generator: "portal-rs" --- # 08:36 ETSonorous Neurovascular Receives FDA Breakthrough Device Designation for BosSTENT™, First Braided Self-Expanding Cerebral Venous Stent, to Treat Debilitating Pulsatile Tinnitus , /PRNewswire/ -- Sonorous Neurovascular, a pioneering medical device company dedicated to advancing neurovascular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the BosSTENT™ device. The FDA's Breakthrough Devices Program aims to provide patients and healthcare providers with more timely access to innovative medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Symptomatic venous sinus stenosis is a primary contributor to debilitating pulsatile (pulse-synchronous) tinnitus. Current treatment options remain limited for many patients. The BosSTENT™, a purpose-built braided, self-expanding stent, delivers an optimized solution through its proprietary design —featuring optimal radiopacity, enhanced visibility, resheathability for precise deployment, and excellent conformability in complex anatomy. "This FDA Breakthrough Device Designation is a major milestone for Sonorous Neurovascular and, most importantly, for the patients suffering from debilitating pulsatile tinnitus," said Joel Harris, President, Sonorous Neurovascular. "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 the safety and performance of the BosSTENT™ in treating pulse-synchronous tinnitus and other symptoms of venous sinus stenosis. Sonorous Neurovascular is advancing clinical trials and regulatory pathways to bring the BosSTENT™ to patients in the United States and beyond. **About Pulsatile (pulse-synchronous) Tinnitus** 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. **About Sonorous Neurovascular** Sonorous Neurovascular is a clinical-stage medical device company focused on developing transformative 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, California, USA, Sonorous Neurovascular is committed to innovation that improves patient outcomes through minimally invasive technologies and diagnostics to enhance patient care. **Contact Information:** James D. Nonato Sonorous Neurovascular Email: \[email protected\] Phone: +1 (949) 810 0055 https://www.sonorousnv.com/ SOURCE Sonorous Neurovascular ### Related Stocks - [IBBQ.US](https://longbridge.com/en/quote/IBBQ.US.md) - [PBE.US](https://longbridge.com/en/quote/PBE.US.md) - [XHE.US](https://longbridge.com/en/quote/XHE.US.md) - [IHE.US](https://longbridge.com/en/quote/IHE.US.md) - [VHT.US](https://longbridge.com/en/quote/VHT.US.md) - [SBIO.US](https://longbridge.com/en/quote/SBIO.US.md) - [BBH.US](https://longbridge.com/en/quote/BBH.US.md) - [FBT.US](https://longbridge.com/en/quote/FBT.US.md) - [STIM.US](https://longbridge.com/en/quote/STIM.US.md) - [ANRO.US](https://longbridge.com/en/quote/ANRO.US.md) - [VIGL.US](https://longbridge.com/en/quote/VIGL.US.md) - [XBI.US](https://longbridge.com/en/quote/XBI.US.md) - [IBB.US](https://longbridge.com/en/quote/IBB.US.md) - [XLV.US](https://longbridge.com/en/quote/XLV.US.md) - [BIB.US](https://longbridge.com/en/quote/BIB.US.md) - [IXJ.US](https://longbridge.com/en/quote/IXJ.US.md) - [IHI.US](https://longbridge.com/en/quote/IHI.US.md) - [ARKG.US](https://longbridge.com/en/quote/ARKG.US.md) ## Related News & Research - [Grupa Azoty announces extraordinary shareholder meeting](https://longbridge.com/en/news/297635728.md) - [Koala trial doses first patient with novel KMA‑targeting CAR‑T](https://longbridge.com/en/news/298021066.md) - [“We’re not doing 30 bets a year”: Vijay Pande on betting small after running $4 billion at a16z](https://longbridge.com/en/news/297407072.md) - [EverGen Infrastructure Reports Q2 2026 Results | EVGIF Stock News](https://longbridge.com/en/news/297122882.md) - [Biotech Stocks Facing FDA Decision In September 2026](https://longbridge.com/en/news/297065559.md) --- > **Disclaimer: This article is for reference only and does not constitute any investment advice.**