Sonorous Neurovascular Receives FDA Clearance for Novel BosCATH™ Neurovascular Catheter

Sonorous Neurovascular has received 510(k) clearance from the US Food and Drug Administration (FDA) for its BosCATH™ neurovascular catheter, a next-generation device developed to improve access and procedural efficiency in complex cerebral venous and arterial procedures.

The BosCATH™ catheter has been designed to provide improved trackability, navigability and support during challenging neurovascular interventions. 

The device is intended to assist physicians in delivering advanced therapies within difficult venous anatomies and complements the company’s expanding neurovascular portfolio.

The regulatory clearance follows the company’s recent FDA Breakthrough Device Designation for its BosSTENT™, a braided self-expanding cerebral venous stent developed for the treatment of symptomatic cerebral venous sinus stenosis associated with pulsatile tinnitus.

According to the company, the BosCATH™ catheter has been specifically engineered to support the delivery of devices such as BosSTENT™ during minimally invasive procedures. 

The FDA clearance allows Sonorous Neurovascular to commercialise the device in the United States, expanding treatment options for interventional neuroradiologists and neurosurgeons.

Sonorous Neurovascular has also launched the international B-SILENT clinical study (NCT07070089) across France and Canada to evaluate the investigational use of BosSTENT™ in patients with pulsatile tinnitus caused by cerebral venous sinus stenosis. 

The study is expected to generate clinical data supporting a future CE Mark submission.

The company continues to advance its neurovascular clinical programmes across both US and international regulatory pathways.