FDA Clears Morph DNA Catheter to Guide Cell Delivery into Heart Tissue

BioCardia, a Silicon Valley firm, won FDA clearance for its Morph DNA catheter, a device developed to help with delivery of the company’s CardiAMP cell therapy into the heart. CardiAMP involves depositing a patient’s own bone marrow cells into heart tissue, with the intention of jump starting the body’s natural healing processes to reverse previous damage that has occurred in the heart.

The Morph DNA deflectable catheter is used to guide the Helix delivery system toward multiple targets inside the heart. The Helix injects cell therapy agents directly into cardiac tissue, potentially resulting in significant benefits to patients.

The Morph DNA features bidirectional deflection, a low tendency for torque build up and whip lash, better visibility under the fluoroscope, and an ergonomic design, according to the company. The new catheter uses pull wires that are braided into a helix, similar to DNA strands, an arrangement that gives the device its name. This configuration helps to reduce whips when navigating around curvy vasculature and when inside the heart.

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

“Our investigational Helix delivery system using the original Morph technology has shown a great safety profile and has been shown to be dramatically more efficient in helping the heart retain cell therapy when compared to other leading delivery approaches,” added BioCardia CEO Peter Altman, PhD. “The new Morph DNA device is an elegant product intended to further enhance the performance of our biotherapeutic delivery capabilities, and through these, our CardiAMP and CardiALLO cell therapy programs.”

Here’s a Biocardia video describing the Helix delivery system:

Related studies: Improvement of Local Cell Delivery Using Helix Transendocardial Delivery Catheter in a Porcine Heart; Not All Stem Cells Are Created Equal

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