BioCardia Submits 510(k) Application for AVANCE Steerable Introducer for Transseptal Heart Access

BioCardia Inc., a developer of comprehensive solutions for cardiovascular regenerative therapies, announced its 510(k) submission for U.S. Food and Drug Administration (FDA) clearance of the AVANCE steerable introducer, designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum.
 
The AVANCE steerable introducer leverages new technology developed for BioCardia’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 pull-wires, and provides exceptional torsional stiffness. AVANCE also offers a rotating hemostasis port. These features are intended to enable greater predictability, stability and control during procedures.
 
“The best-in-class design that underlies AVANCE was developed to enhance delivery of our investigational CardiAMP and CardiALLO cell therapies,” said BioCardia CEO Peter Altman, Ph.D. “We are excited about making this product available to the broader transseptal market, and expect it to favorably impact revenues in the second half of 2019.”
 
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 size is currently estimated to be valued at over $550 million and is expected to increase at a compound annual growth rate (CAGR) of 11.7 percent from 2018 to 2028.¹
 
BioCardia Inc., headquartered in San Carlos, Calif., is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the company’s biotherapeutic product candidates in clinical development. The company’s current products include the Helix Biotherapeutic Delivery System and the Morph steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.

Reference
¹ Bekryl Market Analysts (2018). Global Transseptal Access Systems Market Size Analysis, 2018-2028. New York, NY.