Avance steerable introducer given FDA 510(k) clearance


The AVANCE steerable introducer product family (BioCardia) has received US Food and Drug Administration (FDA) 510(k) clearance. The AVANCE device is designed to introduce various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum.

According to BioCardia, the AVANCE steerable introducer family leverages Morph “DNA” technology, which is an enhancement of the company’s FDA-cleared Morph steerable introducer; this adds several features that make the devices ideal for use in transseptal procedures, and they are designed to improve upon commercially-available offerings. In a press release the company states that the devices are virtually whipless around curves, due to their helically arranged pull-wires, which enable greater predictability, stability and control during procedures. They are bidirectional, which further enhances control within the heart. And they allow for better catheter conformance to patient anatomy and easier navigation through tortuous anatomy. AVANCE devices also offer a rotating haemostasis side port, which helps reduce physician frustration with tangled fluid lines during a procedure. Three configurations of the device are available.

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.


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