Core Insights - BioCardia, Inc. has received FDA clearance to market the Morph DNA Steerable Introducer product family, which is designed for use in cardiovascular and pulmonary disease treatments [1][2] - The Morph DNA product family includes sixteen products with various lengths and diameters, aimed at enhancing interventional cardiology and related procedures [1][2] Product Overview - The Morph DNA Steerable Introducer allows for the introduction of medical instruments into the peripheral and coronary vasculature, covering a range of clinical applications [1][2] - The product family is expected to improve procedures such as renal denervation, endovascular aortic repair, and atrial fibrillation mapping and ablation, potentially benefiting over a million procedures annually in the U.S. [2][3] Design Features - The Morph DNA design includes bidirectional steering, ergonomic actuation, and a proprietary layup for torque response, aimed at enhancing control and navigation during procedures [4] - The design incorporates tensioning elements that allow for consistent catheter performance and smooth navigation, reducing the risk of sudden movements during use [4] Company Background - BioCardia is a leader in cellular and cell-derived therapeutics, with a focus on cardiovascular and pulmonary diseases, and has three clinical stage product candidates in development [5]
BioCardia Announces FDA Market Clearance of Morph® DNA™ Steerable Introducer Product Family