BioCardia Seeks FDA Clearance for Avance Steerable Introducer for Transseptal Access
December 17, 2018—BioCardia, Inc. announced its submission for FDA 510(k) clearance of its Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum (ie, transseptal access).
According to BioCardia, the Avance steerable introducer leverages technology developed for the company's Morph family of steerable introducers and applies it for transseptal procedures. The bidirectional Avance is designed to be virtually whipless around curves, due to its helically arranged pullwires, and provides torsional stiffness. The device also offers a rotating hemostasis port. These features are intended to enable greater predictability, stability, and control during procedures.