May 16, 2019 — BioCardia Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Avance steerable introducer product family, designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum.
The company showed the Avance device at the Heart Rhythm Society’s (HRS) 2019 Heart Rhythm Scientific Sessions conference, May 8-11 in San Francisco.
The Avance steerable introducer family leverages Morph “DNA” technology, an enhancement of the company’s FDA-cleared Morph steerable introducer. The enhancement adds several features that make the devices ideal for use in transseptal procedures and are designed to improve upon commercially available offerings. The devices are virtually whipless around curves due to their helically arranged pull-wires, enabling greater predictability, stability and control during procedures. They are bidirectional, which further enhances control within the heart. They allow for better catheter conformance to patient anatomy and easier navigation through tortuous anatomy. Avance devices also offer a rotating hemostasis 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. The global transseptal access systems market value is currently estimated at $490 million and is expected to increase at a compound annual growth rate (CAGR) of 10.4 percent from 2017 to 2024.1
For more information: www.biocardia.com