BioCardia’s AVANCE steerable introducer family has received FDA 510(k) clearance, the company announced May 8.
The AVANCE family, according to a statement, is designed to facilitate the introduction of various cardiovascular catheters into the heart. The AVANCE steerable introducer builds on one of BioCardia’s previous successes—the FDA-approved Morph steerable introducer—by leveraging Morph DNA technology and offering an improved product with more useful features.
BioCardia said AVANCE steerable introducer devices are “virtually whipless around curves” because they have helically arranged pull-wires, allowing for better predictability, stability and control during catheter procedures. They’re also bidirectional, which helps catheters better conform to a patient’s anatomy and enables easier navigation through tricky areas.
AVANCE devices also sport a rotating hemostasis sideport—a feature that helps keep fluid lines from tangling with one another, ideally easing physicians’ frustration with difficult procedures. As of now, three configurations of AVANCE are available for commercial use.
Peter Altman, PhD, CEO of BioCardia, said in the company’s statement that transseptal delivery is common in many cardiac procedures, including atrial fibrillation ablation, patent foramen ovale and atrial septal defect repair, percutaneous mitral valve repair, left atrial appendage closure and percutaneous left ventricular assist device placement.
“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,” he said. “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.”