Lake Forest, California-based Sonorous designed its BosCATH system to enhance access, delivery and procedural efficiency in complex cerebral venous and arterial anatomies.
The company said its device provides physicians with superior trackability, support and navigability in challenging neurovascular procedures.
FDA clearance comes on the heels of breakthrough device designation for its BosSTENT cerebral venous stent system as well. The company designed that braided, self-expanding stent to treat cerebral venous stenosis associated with debilitating pulsatile tinnitus. BosCATH adds to the Sonorous portfolio and supports the delivery of 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 Joel Harris, CEO of Sonorous Neurovascular. “We extend our sincere thanks to the entire Sonorous R&D and regulatory teams for their outstanding dedication and expertise. In particular, we recognize Jake Le, [VP] of R&D, for his exceptional leadership in driving product development from concept to successful 510(k) clearance.”
Sonorous also noted that it initiated its international B-SILENT study in France and Canada. The study evaluates the investigational use of the BosSTENT for treating debilitating pulsatile tinnitus caused by symptomatic cerebral venous sinus stenosis. It aims to use the findings to support a future CE mark submission.
