FDA Clearance of Steerable Introducer for Transseptal Access/Delivery

BioCardia®, Inc., a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, says the U.S. FDA has cleared its 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.

Background

Transseptal delivery of cardiac devices is growing as the approach is considered to solve many problems that clinicians face every day delivering devices for AFib, percutaneous mitral valves, LAA and other important procedures.

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.

The AVANCE steerable introducer family employs Morph “DNA” technology, an enhancement of BioCardia’s FDA-cleared Morph steerable introducer, which adds several features that make the devices ideal for use in transseptal procedures and are designed to improve upon commercially-available offerings. For example the devices are described as “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.

BioCardia showed the AVANCE device at the Heart Rhythm Society’s Heart Rhythm Scientific Sessions conference in San Francisco last week.

Company comments

“We have successfully used our existing Morph products in more than 10,000 clinical procedures to date, including hundreds of cases to deliver cell and gene therapies to the heart,” said BioCardia CEO Peter Altman, PhD. “The success of these products led us to further enhance them for the delivery of our investigational CardiAMP and CardiALLO cell therapies, as well as other clinical applications including transseptal procedures.”

 

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