BioCardia Seeks FDA Clearance for Avance Steerable Introducer for Transseptal Access

 

December 17, 2018—BioCardia, Inc. announced its submission for FDA 510(k) clearance of its Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum (ie, transseptal access).

According to BioCardia, the Avance steerable introducer leverages technology developed for the company's Morph family of steerable introducers and applies it for transseptal procedures. The bidirectional Avance is designed to be virtually whipless around curves, due to its helically arranged pullwires, and provides torsional stiffness. The device also offers a rotating hemostasis port. These features are intended to enable greater predictability, stability, and control during procedures.

 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.