Sonorous Neurovascular has received breakthrough device designation from the US Food and Drug Administration (FDA) for its braided, self-expanding cerebral venous stent, BosSTENT, for treating pulsatile tinnitus caused by symptomatic venous sinus stenosis.
The device is designed to address limitations in current treatment options for patients with this condition.
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The FDA’s breakthrough devices programme is intended to expedite access to medical devices that could offer more effective treatment or diagnosis for life-threatening or permanently debilitating conditions.
BosSTENT has been developed as a purpose-built device with specific features such as enhanced radiopacity, visibility, resheathability for accurate deployment, and conformability to accommodate complex neurovascular anatomy.
The designation follows the device’s initial clinical use in humans and continuing studies that evaluate its performance and safety in treating pulse-synchronous tinnitus and other symptoms related to venous sinus stenosis.
Sonorous Neurovascular continues to advance its clinical trial activities and regulatory submissions with the intention of making BosSTENT available in the US and other markets.
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By GlobalDataPulsatile tinnitus manifests as a rhythmic sound in one or both ears corresponding with the heartbeat. The condition typically results from vascular or circulatory issues, often linked to abnormal blood flow near the ear due to cerebral venous sinus abnormalities.
Sonorous Neurovascular president Joel Harris said: “This FDA breakthrough device designation is a major milestone for Sonorous Neurovascular and, most importantly, for the patients suffering from debilitating pulsatile tinnitus.
“The BosSTENT represents years of focused innovation to deliver an on-label, minimally invasive solution that normalises venous haemodynamics 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 programme to accelerate access to treating patients.”
