Helix Biotherapeutic Delivery System
Leading physicians have described the current Helix Biotherapeutic Delivery System as elegant in its simplicity.
BioCardia’s Helix Biotherapeutic Delivery 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.
The Helix catheter's small hollow, distal helical 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 provides for stability and control during the delivery procedure. It uses simplified fluoroscopic imaging, crosses the aortic arch and valve over a guide wire, and provides the operator with three degrees of freedom to maximize operator control.
The Helix catheter has received CE Mark for the European Union. It is under investigational use in the United States and is being used in pre-clinical and clinical investigations of cell, gene, and protein therapies.
Caution: Investigational Device. Limited by United States Law to investigational use.
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