MyoTEC™ System – the percutaneous catheter for myocardial tissue engineering

The MyoTEC™ system is an injection system to deliver Algisyl® or other fluids and viscous fluids (gels) into the heart muscle from the left ventricle (endocardial or inside of the heart) rather than from the outer surface of the heart (epicardial). To accomplish this, a commonly practiced percutaneous technique is used whereby the device is inserted through a small skin opening into an artery. In the case of MyoTEC™, the artery in question (Superficial Femoral Artery) is located in the upper leg in the groin area. From that point of access, the catheter navigates upwards into the ventricle by passing through the aorta, the aortic arch, and the aortic heart valve. The benefit of a percutaneous access is in the ease of introducing devices without the use of large cut downs and chest surgery which require full anesthesia and carry greater post-operative risks.

The MyoTEC™ system consists of the following components at its distal end that are assembled like a telescope and deployed sequentially once the left ventricle is reached:

  1. A deflectable navigation catheter that can rotate or torque for navigation inside of the left ventricle. The navigation catheter allows the cardiologist to position MyoTEC™ in the area where an injection is desired.
  2. A stabilization catheter is deployed next to provide final position control and to affix the device to the surface of the heart muscle where the injection will take place. The tip of the stabilization catheter has a soft, flexible stabilization hood that provides visualization markers and confirms proper wall attachment and isolation of the injection area.
  3. An injection needle of less than one half millimeter in diameter located Inside of the stabilization catheter is advanced next under fluoroscopic guidance into the heart tissue. Once the location of the needle inside the muscle is confirmed, the Algisyl® gel can be injected in a slow, deliberate fashion.

The MyoTEC™ System is currently being evaluated for clinical use with Algisyl®. Clinical studies in Europe and in the US are expected later in 2017.

CAUTION: Investigational device. Limited by United States law to investigational use only.