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FDA grants clearance for steerable introducer for transseptal access
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BioCardia announced it has received FDA clearance for a steerable introducer used for transseptal access to the heart.
The steerable introducer (AVANCE) is virtually whipless around the curves due to helically arranged pull-wires, a design to enhance predictability, stability and control during procedures, the company stated in a press release.
Procedures that utilize transseptal delivery include AF ablation, PFO and atrial septic defect repair and PCI, among others, according to the release.
“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, PhD, BioCardia CEO, said in the 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 transseptal procedures.”
BioCardia showcased the device during the Heart Rhythm Scientific Sessions, according to the release.
Disclosures: Altman is an employee of BioCardia.