Lake Forest, California, USA – April 22, 2026

In a significant advancement for neurovascular intervention technology, Sonorous Neurovascular has received U.S. FDA 510(k) clearance for its BosCATH™ neurovascular catheter, a next-generation device designed to improve access, precision, and procedural efficiency in complex cerebral vascular anatomies. This milestone strengthens the company’s position in the rapidly evolving minimally invasive neurovascular device market, addressing critical unmet needs in the treatment of cerebral venous diseases and interventional neurology procedures.

Next-Generation Catheter Enhances Neurovascular Access

The newly cleared BosCATH™ catheter has been engineered to deliver superior trackability, navigability, and support, enabling physicians to more effectively access tortuous cerebral venous and arterial pathways. These features are particularly important in complex neurovascular procedures, where precision and device control directly impact clinical outcomes.

BosCATH is specifically designed to facilitate the delivery of advanced therapeutic devices, including the company’s investigational BosSTENT™, a braided self-expanding stent intended for treating cerebral venous sinus stenosis. By improving access and device deployment capabilities, BosCATH enhances the efficiency and reliability of minimally invasive procedures, helping clinicians navigate challenging anatomical structures with greater confidence.

This innovation reflects a broader trend in neurointerventional care, where device design is increasingly focused on enabling safer, faster, and more effective treatment delivery in high-risk vascular environments.

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Regulatory Milestones Strengthen Device Portfolio

The FDA 510(k) clearance of BosCATH follows the company’s recent achievement of Breakthrough Device Designation for its BosSTENT™ system, highlighting Sonorous Neurovascular’s growing momentum in regulatory advancement and product development. Together, these milestones position the company to deliver a comprehensive, purpose-built neurovascular solution targeting both device access and therapeutic intervention.

The clearance enables immediate commercialization of BosCATH in the United States, expanding treatment options for interventional neuroradiologists and neurosurgeons. This is particularly relevant as demand for minimally invasive neurovascular procedures continues to rise, driven by increasing prevalence of conditions such as pulsatile tinnitus and cerebral venous disorders.

Sonorous is also advancing its global clinical strategy, including the ongoing B-SILENT study, which is evaluating the investigational use of BosSTENT in patients with symptomatic cerebral venous sinus stenosis. The study aims to generate critical data supporting future CE Mark approval in Europe, further expanding the company’s international footprint.

Advancing Minimally Invasive Neurovascular Therapies

Cerebral venous diseases, including conditions associated with pulsatile tinnitus, represent a growing area of clinical focus with limited effective treatment options. These disorders can significantly impact patient quality of life, often causing chronic symptoms such as noise perception, neurological discomfort, and reduced functional capacity.

By combining innovative catheter technology with advanced stent systems, Sonorous Neurovascular aims to deliver targeted, minimally invasive solutions that address both the underlying vascular abnormalities and procedural challenges. The BosCATH catheter plays a critical role in this ecosystem, enabling precise delivery of therapeutic devices and improving procedural outcomes.

As healthcare systems increasingly prioritize minimally invasive interventions, technologies like BosCATH are expected to play a key role in reducing procedural risk, shortening recovery times, and enhancing patient outcomes. The integration of advanced device platforms also supports the shift toward personalized neurovascular care, where treatments are tailored to individual patient anatomy and disease characteristics.

This FDA clearance underscores Sonorous Neurovascular’s commitment to innovation in neurointerventional medicine, reinforcing its mission to develop transformative technologies that improve the lives of patients with complex vascular conditions. As clinical programs continue to advance and regulatory pathways expand, the company is well positioned to become a key player in the future of neurovascular therapy.

Source: Sonorous Neurovascular press release