FDA News

Guide catheter for cardiac cell therapy delivery cleared

BioCardia announced that the FDA granted clearance to its deflectable guide catheter for delivery of cell therapy to the heart.

The catheter (Morph DNA) is used to guide a biotherapeutic delivery system (Helix) during cell therapy delivery (CardiAMP) to the heart, according to a press release from the company.

According to the release, the catheter is designed to be easier to use than previous catheters via bidirectional deflection, reduced torque buildup, better fluoroscopic visibility, better ergonomics, enhanced stability and a new handle design for improved control.

“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,” Gerald Koenig, MD, PhD, cardiologist at Henry Ford Health System and principal investigator of the CardiAMP Heart Failure Trial, said in the release.

Disclosure: Koenig reports he is principal investigator of a trial sponsored by BioCardia.

BioCardia announced that the FDA granted clearance to its deflectable guide catheter for delivery of cell therapy to the heart.

The catheter (Morph DNA) is used to guide a biotherapeutic delivery system (Helix) during cell therapy delivery (CardiAMP) to the heart, according to a press release from the company.

According to the release, the catheter is designed to be easier to use than previous catheters via bidirectional deflection, reduced torque buildup, better fluoroscopic visibility, better ergonomics, enhanced stability and a new handle design for improved control.

“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,” Gerald Koenig, MD, PhD, cardiologist at Henry Ford Health System and principal investigator of the CardiAMP Heart Failure Trial, said in the release.

Disclosure: Koenig reports he is principal investigator of a trial sponsored by BioCardia.