BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of steerable introducers and applies the same technology for transseptal procedures.
BioCardia touted that the Avance introducer is intended to be virtually whipless around curves due to helically arranged pull-wires, and added that the system also offers a rotating hemostasis port.
“The best-in-class design that underlies Avance was developed to enhance delivery of our investigational CardiAMP and CardiALLO cell therapies. 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,” BioCardia CEO Peter Altman said in a press release.
In August, BioCardia touted data from the first 10 patients treated in its Phase III CardiAmp heart failure trial.