BioCardia Submits for FDA Approval of Morph DNA Steerable Introducer Product Family
July 31, 2024 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, reported it has submitted a 510(k) for approval of its patented Morph DNA Steerable Introducer Sheath. This product family is intended 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 filing for approval of this product family follows the FDA approval of BioCardia’s Helix biotherapeutic delivery Morph DNA guide system and its Avance transseptal steerable introducer, both of which incorporate Morph DNA technology. Morph DNA designs enable the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements appear as a double
