Sonorous Neurovascular has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for BosCATH, a next-generation neurovascular catheter designed to enhance access, delivery and procedural efficiency in complex cerebral venous and arterial anatomies.
This clearance allows Sonorous to commercialise BosCATH in the USA, expanding treatment options for interventional neuroradiologists and neurosurgeons, the company states in a press release.
BosCATH is engineered to provide physicians with superior trackability, support and navigability in challenging neurovascular procedures, according to Sonorous, with the company noting in its recent release that the device complements its innovative portfolio and has been specifically designed to support delivery of advanced therapies like the BosSTENT in tortuous venous anatomy.
“This 510(k) clearance for BosCATH, combined with our recent Breakthrough Device designation for BosSTENT, represents important progress in our mission to deliver purpose-built devices that address significant unmet needs in neurovascular care,” said Sonorous chief executive officer (CEO) Joel Harris. “We extend our sincere thanks to the entire Sonorous R&D [research and development] and regulatory teams for their outstanding dedication and expertise. In particular, we recognise Jake Le, vice president of R&D, for his exceptional leadership in driving product development from concept to successful 510(k) clearance.”
Sonorous has also initiated the international B-SILENT study in France and Canada to evaluate the investigational use of the BosSTENT device for the treatment of debilitating pulsatile tinnitus caused by symptomatic cerebral venous sinus stenosis. This clinical study is designed to generate “essential” safety and performance data to support a future CE-mark submission, the company says.
