BioCardia Morph DNA Steerable Introducer Product Family Cleared by FDA

September 10, 2024—BioCardia, Inc. recently announced that the FDA has cleared the company’s Morph DNA steerable introducer product family.

According to the company, the Morph DNA devices are intended to introduce medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, into the peripheral vasculature, coronary vasculature, or heart chambers. The clearance covers 16 products in 30-, 45-, 71-, and 90-cm lengths in 5-, 6-, 7-, and 8-F introducer sheath-equivalent diameters.

BioCardia stated that these products are expected to cover most clinical applications in interventional cardiology, interventional radiology, cardiac electrophysiology, and vascular surgery.

The products are also expected to enhance peripheral vascular intervention for contralateral access, renal denervation for the treatment of high blood pressure, endovascular aortic repair, carotid artery stenting, and the treatment of perivalvular leaks in structural heart procedures, as well as left heart access for the mapping and ablation of atrial fibrillation.

The company advised that the Morph DNA steerable introducer family has bidirectional steering, a layup for torque response, ergonomic actuation, an adjustable brake for fine control, and a swiveling side port in its hemostasis valve to solve tangling issues and enhance procedures.

The design of the Morph DNA devices contain tensioning elements in the catheter that rotate around the catheter shaft, allowing consistent catheter performance in any direction—resembling the double helix in a strand of DNA. The design is intended to enable smooth navigation and prevent “whip,” when the build-up of mechanical forces in the device causes a catheter to suddenly jump from one orientation to another.