Helix Biotherapeutic Delivery - Overview
BioCardia’s Helix biotherapeutic delivery catheter system is the leading percutaneous catheter delivery system for cardiovascular regenerative medicine. It enables local delivery of cell and gene based therapies to treat heart failure, myocardial infarction, ischemia, and cardiac conduction disorders. Helix delivery provides for a catheter located within the left ventricular space with a penetrating element for delivery through the endocardium to a depth within the myocardium.
The Helix catheter's small hollow, distal corkscrew needle is advanced from a blood vessel in the groin similar to an angioplasty catheter, over the aortic arch and across the aortic valve through the FDA cleared Morph guide catheter. The Helix is then advanced from the Morph, and its helical needle is rotated into the heart tissue to provide active fixation during therapeutic delivery, similar to the active fixation electrodes used in cardiac pacing. This fixation to the beating heart wall provide for stability and control during the delivery procedure. It uses simplified fluoroscopic imaging, crosses the aortic arch and valve safely over a guide wire, and provides the operator with three degrees of freedom to maximize operator control. Leading physicians have described the current Helix system as elegant in its simplicity.
The Helix catheter is under investigational use in the United States and CE Mark approved for the European Union.