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BioCardia Announces FDA Market Clearance of Morph® DNA™ Steerable Introducer Product Family
SUNNYVALE, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the
About this update from Biocardia, Inc.
[{"type":"text","content":"SUNNYVALE, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Food and Drug Administration (FDA) has cleared BioCardia to market the Morph DNA Steerable Introducer product family, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act. The patented Morph® DNA™ Steerable Introducer product family now has FDA market clearance to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart. The clearance covers sixteen products in lengths of 30, 45, 71, and 90 centimeters in 5, 6, 7, and 8 French introducer sheath equivalent diameters. These products are expected to cover most clinical applications in interventional cardiology, interventional radiology, cardiac electrophysiology, and vascular surgery. The product solution is also expected to enhance some of the most common and advanced procedures performed in the United States, including peripheral vascular intervention for contralateral access, renal denervation for the treatment of high blood pressure, endovascular aortic repair, carotid artery stenting, treating perivalvular leaks in structural heart procedures, and enabling left heart access for the mapping and ablation of atrial fibrillation. “BioCardia’s previous Morph product in a single diameter has already been used in each of these various clinical indications, totaling approximately 12,000 commercial procedures,” said Peter Altman PhD, President and CEO. He continued, “We are looking forward to introducing the more advanced Morph DNA products to our valued physician customers and earning their business. Over time, I expect this product family to provide value to physicians and their patients. We estimate that more than a million procedures performed per year in the United States may benefit from these products, which are expected to have a list price starting at $1,000.” “We developed this product initially to address our own needs for enhanced control navigating inside the left ventricle of the heart to perform our CardiAMP® and CardiALLO™ cell therapy proc...