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:
Product page:
Helix Biotherapeutic Delivery System
Flashbacks:
BioCardia’s Intramyocardial Stem Cell Delivery Catheter System Gets European Approval;
Related studies:
Improvement of Local Cell Delivery Using Helix Transendocardial Delivery Catheter in a Porcine Heart;
Not All Stem Cells Are Created Equal
Via:
Biocardia
