FDA clears BioCardia’s Avance transeptal introducer

BioCardia recently announced that it has received FDA 510(k) clearance for its Avance steerable introducer.

The Avance transeptal introducer is designed for introducing catheters into the heart, which includes through the left side of the heart through the intertribal septum. It is whipless around curves because of its helically arranged pull-wires. Advance is also bidirectional and allows doe better catheter conformance to the anatomy of the patient with easier navigation. BioCardia’s Avance devices also offer a rotating hemostasis side port with three configurations of the device.

“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,” Peter Altman, CEO of BioCardia, said in a press release. “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 transeptal procedures.”

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