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January 16, 2020

BioCardia's Morph DNA Deflectable Guide Catheter Cleared by FDA

January 14, 2020—BioCardia, Inc. announced FDA 510(k) clearance for the Morph DNA deflectable guide catheter used to guide the Helix biotherapeutic delivery system during CardiAMP cell therapy delivery in the heart.

According to BioCardia, the Morph DNA is designed to enhance procedural control of therapeutic catheters, such as the Helix system, during delivery of cell therapy. It is intended to provide ease of use through bidirectional deflection, reduced torque build-up or whip, enhanced fluoroscopic visibility, and improved ergonomics.

The company noted that helically arranged pullwires in the device, resembling the double helix of a DNA strand, increase catheter stability, rendering it virtually whipless around curves and within the heart. The device also features a new handle design with an adjustable brake for finer catheter control during procedures.

Gerald Koenig, MD, commented in BioCardia’s press release, “The Morph DNA deflectable guide enables navigation within the cardiac chambers without building up torque. This is hugely beneficial for controlling the delivery of therapeutic catheters, such as Helix. The ergonomic features simplify the handling and can reduce procedural delays.” Dr. Koenig is a cardiologist and Principal Investigator of the CardiAMP Heart Failure Trial at Henry Ford Health System in Detroit, Michigan.

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Study Shows More Than Half of United States Clinical Trials Fail to Comply With Law on Reporting Results

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Three-Year Findings Published for Mortality of Repeat Revascularizations in the EXCEL Trial