Sonorous Neurovascular Receives FDA Breakthrough Device Designation for BosSTENT to Treat Pulsatile Tinnitus
Key Insights
Sonorous Neurovascular (search) has received FDA breakthrough device designation for BosSTENT (search), the first braided, self-expanding cerebral venous stent designed to treat debilitating pulsatile tinnitus (search) caused by symptomatic venous sinus stenosis (search).
The BosSTENT (search) device features enhanced radiopacity, visibility, resheathability for precise deployment, and excellent conformability to accommodate complex neurovascular anatomy.
The FDA designation follows promising early clinical experience including first-in-human uses and ongoing studies evaluating the device's safety and performance in treating pulse-synchronous tinnitus.
Sonorous Neurovascular (search) has received breakthrough device designation from the US Food and Drug Administration (FDA) for its BosSTENT (search) device, a braided, self-expanding cerebral venous stent designed to treat pulsatile tinnitus (search) caused by symptomatic venous sinus stenosis (search). The designation aims to expedite access to this innovative medical device that could offer more effective treatment for patients with this debilitating condition.
Device Design and Innovation
The BosSTENT (search) represents a purpose-built solution with specific features engineered to address limitations in current treatment options. The device incorporates enhanced radiopacity and visibility, resheathability for accurate deployment, and conformability to accommodate complex neurovascular anatomy. These design elements are intended to normalize venous hemodynamics through a minimally invasive approach.
"The BosSTENT (search) 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 (search)," said Joel Harris, President of Sonorous Neurovascular (search).
Clinical Development Progress
The FDA designation follows promising early clinical experience, including initial clinical use in humans and continuing studies that evaluate the device's performance and safety in treating pulse-synchronous tinnitus and other symptoms related to venous sinus stenosis (search). Sonorous Neurovascular (search) continues to advance its clinical trial activities and regulatory submissions with the intention of making BosSTENT (search) available in the US and other markets.
Understanding Pulsatile Tinnitus
Pulsatile tinnitus (search) manifests as a rhythmic whooshing, thumping, or pulsing sound in one or both ears that synchronizes with the individual's heartbeat. The condition typically results from vascular or circulatory issues, often linked to abnormal blood flow near the ear due to cerebral venous sinus (search) abnormalities. Current treatment options remain limited for many patients suffering from this condition.
Regulatory Pathway
The FDA's breakthrough devices program is intended to expedite access to medical devices that could offer more effective treatment or diagnosis for life-threatening or permanently debilitating conditions. This designation provides patients and healthcare providers with more timely access to innovative medical devices that have the potential to provide more effective treatment.
"This FDA breakthrough device designation is a major milestone for Sonorous Neurovascular (search) and, most importantly, for the patients suffering from debilitating pulsatile tinnitus (search)," Harris stated. "We are grateful for the FDA's recognition and look forward to collaborating closely under this program to accelerate access to treating patients."