News | Catheters | October 23, 2019

BioCardia Initiates Commercial Release of Avance Steerable Introducer

Device designed to enhance physician control for complex cardiac procedures

BioCardia Initiates Commercial Release of Avance Steerable Introducer

October 23, 2019 — BioCardia announced the U.S. commercial availability of its Avance Bi-Directional Steerable Introducer Sheath for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The product became available in late September.

An introducer sheath is routinely used by electrophysiologists (EPs) and interventional cardiologists (ICs) to facilitate complex conditions such as atrial fibrillation and structural heart procedures. The Avance device addresses the shortcomings of currently available steerable introducers with its Morph DNA technology, creating a high-performance steerable introducer for superior control during complex procedures.

The Avance catheter is designed to have uniform bending characteristics in all directions by having the two tendon wires wrap helically around the catheter shaft, like the double helix in DNA. The uniform bending characteristics where critically important are intended to reduce what EPs and ICs refer to as “whip” in catheter navigation, where the catheter jumps to a new location in an uncontrolled fashion.

The product is designed with a smooth tip-to-dilator transition, which promotes ease of entry into the left atrium during transseptal access. Deflections of 180 degrees in both directions are designed to provide increased steerability, which may improve access to hard-to-reach sites.

The Avance device was recently used on a patient at John F. Kennedy Hospital (JFK) in West Palm Beach, Fla.

“One of our overall goals is to enhance procedural control by improving products used during procedures,” said Robert Fishel, M.D., director of electrophysiology at JFK. “The Avance product performed well in our hands and we found it competitive.”

The Avance device will have a limited launch while the company seeks feedback from EPs and ICs on real-world use and explores options for manufacturing at scale.

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

Related Content

SpectraWave is developing a a new intravascular imaging system that combines two currently available modalities. This likely includes optical coherence tomography (OCT), left, which can define structures within the vessel and vessel wall.  Near infrared spectroscopy (NIRS), right, enables a spectral chemical analysis of the vessel walls to show areas of high lipid content, and specifically can identify lipid-core plaques that are associated with heart attack-causing plaque ruptures.

News | Cath Lab | February 16, 2021
February 16, 2021 – SpectraWave Inc.
Videos | Cath Lab | February 04, 2021
Cindy Grines, M.D., MSCAI, FACC, president
Among high-risk, chronic, coronary patients who undergo angioplasty, there were no additional benefits from ticagrelor compared to the current standard of care clopidogrel. #AHA #AHA20 #AHA2020
News | Cath Lab | November 16, 2020
November 16, 2020 — The use of the more potent antiplatelet medication ticagrelor (Brilinta) was not superior to clop
A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) in the treatment of peripheral artery disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischemic limb and cardiovascular outcomes was consistent regardless of whether a DCD was used. #TCT2020 #TCTconnect
Feature | Cath Lab | October 18, 2020
October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benef
A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin capped fibrous atheroma (TCFA). #TCTconnect #TCT2020

A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin cap fibro-atheroma (TCFA).

News | Cath Lab | October 18, 2020
October 18, 2020 – Data from the...
The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions. #TCT2-0

The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions.

Feature | Cath Lab | October 16, 2020
October 15, 2020 — Shockwave Medical's Intravascular Lithotripsy (IVL) system to treat severely calcified coronary ar
Videos | Cath Lab | October 16, 2020
This is an example pf the Shockwave Medical Intravascular Lithotripsy (IVL) catheter system designed to break up heav
Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over