BioCardia submits 510(k) application to US FDA for its Avance steerable introducer for transseptal access to heart

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Avance

BioCardia has announced its 510(k) submission for US FDA clearance of the Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. A press release reports that the Avance steerable introducer leverages new technology developed for BioCardia’s Morph family of steerable introducers and applies it for transseptal procedures.

It adds that the bidirectional Avance is designed to be virtually whipless around curves, due to its helically arranged pull-wires, and provides exceptional torsional stiffness. Avance also offers a rotating haemostasis port. These features are intended to enable greater predictability, stability and control during procedures.

Procedures that leverage transseptal delivery include atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and percutaneous left ventricular assist device placement, among others.

BioCardia CEO Peter Altman comments: “The best-in-class design that underlies Avance was developed to enhance delivery of our investigational CardiAMP and CardiALLO cell therapies. We are excited about making this product available to the broader transseptal market, and expect it to favorably impact revenues in the second half of 2019.”

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