Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer

Following its recent FDA clearance, BioCardia, Inc. has confirmed the U.S. commercial availability of the 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.

Background

BioCardia describes itself as a leader in the development of comprehensive solutions for cardiovascular regenerative therapies. Its AVANCE™ device claims to address the shortcomings of currently available steerable introducers with its unique patent protected “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, somewhat akin to 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 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.

Physician comments

Robert Fishel, MD, director of Electrophysiology at John F. Kennedy Hospital (JFK) in West Palm Beach, Florida stated; “One of our overall goals is to enhance procedural control by improving products used during procedures. The AVANCE product performed well in our hands and we found it competitive.”

Company comments

“The AVANCE product incorporates a significant advance in catheter technology,” said BioCardia CEO Peter Altman, PhD. “ Our team developed the rotating pull wire technology for our cell therapy procedures in the left ventricle of the heart and recognized that it could also significantly benefit patients by enhancing physician control in complex cardiac procedures.”  

Source: BioCardia, Inc.

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