BioCardia has filled in another piece of the CardiAmp Cell Therapy puzzle with a new clearance from FDA. The San Carlos, CA-based company has received a nod from the federal agency to market the Morph DNA deflectable guide catheter.
The device is used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart.
CardiAMP cell therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to treat heart failure. The company said the procedure takes under an hour.
“The Morph DNA … is a very elegant catheter technology,” Peter Altman, BioCardia, CEO told MD+DI. “What this catheter does is it solves the problem of torque build up in steerable catheter shafts, caused by the tensioning elements that enable the catheter to be steerable.”
He added, “when you have a tensioning element in a catheter, the catheter will then have different bending characteristics depending on which direction you bend it. What we have done in this Morph DNA and why we call it the Morph DNA is because we have this double helix of two tensioning pull wires, that rotate down the catheter shaft. Because they are rotating down the catheter shaft, the catheter can behave the same way in all the directions mechanically. That eliminates the torque buildup.”
While the Morph DNA clearance is a milestone – the company is still pushing to get CardiAMP approved and on the market.
“The approval pathway will be the IDE/PMA pathway and the trial that we’re performing is a 260-patient trial,” Altman said. “We’re continuing to enroll in this program today and we last reported out in December that we had enrolled a total of 65 patients. Once we have the trial completely enrolled, we will have a one-year follow-up to the primary endpoint and then we will have top-line data. We would anticipate if the data is as we would expect that we would have another year after having that data to secure the approval.”