BioCardia
Overview

Helix Biotherapeutic Delivery

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.


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 provide 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. 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.



Helix™ Transendocardial Delivery Systems

Helical Infusion Catheter

pdfDownload Helix™ Transendocardial Delivery Systems Brochure

Description

  • Transendocardial intramyocardial delivery catheter
  • Active fixation and infusion through hollow helical needle
  • Double barrel contrast port for marking of delivery location with discharge at base of helical needle

Status

  • CE Mark approval received
  • Investigational use only in the United States

Indications

  • This system is available for investigational use only and is being used in preclinical and clinical investigations of cell, gene, and protein therapies.


Caution: Investigational Device.  Limited by United States Law to investigational use.