Technology | Catheters | May 16, 2019

Biocardia Receives FDA Clearance for Avance Steerable Introducer Family

Product family designed for transseptal access to heart in variety of cardiac procedures

Biocardia Receives FDA Clearance for Avance Steerable Introducer Family

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

 

Reference

1. Persistence Market Research (2017). “Transseptal Access Systems Market: Global Industry Analysis (2012-2016) and Forecast (2017-2025).” New York, NY. Persistence Market Research Pvt. Ltd.

Related Content

People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival
News | Cath Lab | September 25, 2019
Ten-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomized...
Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy
News | Cath Lab | September 03, 2019
Shockwave Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)...
Compound Could Help Improve Heart Attack Recovery
News | Cath Lab | August 27, 2019
Imagine there were a drug that you could take soon after a heart attack that could reduce damage by protecting healthy...
New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Overlay Init