Cell therapy system for treatment of HF gains breakthrough device designation from FDA
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BioCardia announced the FDA has granted breakthrough device designation to its cell therapy system for the treatment for HF.
According to a company release, the system (CardiAMP) uses a patient’s own bone marrow cells delivered to the heart using a minimally invasive intramyocardial delivery system (Helix). This approach allows the patient to be discharged the morning after the procedure.
The FDA previously approved the guide catheter for the company’s delivery system (Morph DNA) in January 2020.
The cell therapy system is designed to stimulate a beneficial paracrine reaction to repair the heart.
The system has shown no incidence of mortality at 1 year in its Phase II trial or in the 10-patient roll-in cohort from the Phase III trial that is currently enrolling, the company stated in the release.
As Healio previously reported, the CardiAMP-HF pivotal trial enrolled patients with ischemic cardiomyopathy and left ventricular ejection fraction between 20% and 40%. The primary outcome is change in 6-minute walk distance adjusted for major adverse CV events at 12 months.
“The novelty of this trial relates to the cell potency assay used to select patients who have bone marrow cell characteristics that have been associated with benefits in prior cell therapy trials,” Cardiology Today Chief Medical Editor Carl Pepine, MD, MACC, Eminent Scholar Emeritus and professor in the division of cardiovascular medicine at University of Florida, told Healio.
The trial is scheduled to have a prespecified formal Data Safety Monitoring Board Review on Feb. 8, 2022.
“It is exciting for the field of cardiology that the FDA has recognized the potential of a cell therapy to improve the lives of patients struggling with heart failure. Getting this therapy fast-tracked and to patients more quickly than traditional methods would give us new options and a greater armamentarium to assist our patients in need. I am enthusiastic about completing the U.S. pivotal trial of the CardiAMP Cell Therapy to build the body of evidence necessary to support this accelerated FDA path,” Pepine said in the release.
Breakthrough therapy designation is designed to expedite the development and review of therapies that are intended to treat a serious condition where preliminary clinical evidence indicates potentially substantial improvement over available therapies on a clinically significant endpoint.
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