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

TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
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.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

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.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...