BioCardia has submitted its application for 510(k) with US Food and Drug Administration (FDA), for its new product, AVANCE steerable introducer, designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum.


Image: BioCardia submits 510(k) application for AVANCE Steerable Introducer with FDA. Photo: Courtesy of yodiyim/

The AVANCE steerable introducer leverages new technology developed for BioCardia’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 pull-wires, and provides exceptional torsional stiffness. AVANCE also offers a rotating hemostasis port. These features are intended to enable greater predictability, stability and control during procedures.

BioCardia CEO Peter Altman said: “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.”

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. The global transseptal access systems market size is currently estimated to be valued at over $550m and is expected to increase at a compound annual growth rate (CAGR) of 11.7% from 2018 to 2028.

Source: Company Press Release