New Control System Improves TAVI Delivery

The system is based on an intuitive ergonomic handle with four hollow positioning wires that allow for millimetric control and precise value positioning. The handle also includes a simple to use rotating knob for controlled unsheathing of the valve inside the left ventricle.

The valve is deployed using a standard endoflator that delivers saline pressurized to 12 atmospheres to the expanding rings through the hollow positioning wires. Following initial expansion, the valve remains fully competent throughout the procedure. Once the valve is fully deployed in the annulus, a complete assessment of hemodynamic performance can be performed. Either ring can be de-pressurized to reposition the valve by manipulating the positioning wires, which can be performed repeatedly, if necessary. All Direct Flow Medical valve sizes are implanted with the same delivery system.

When the valve is optimally placed, the saline is easily exchanged via the positioning wires for a quick-curing polymer that forms the permanent structure. During polymer transfer, pressure within the valve is constant and position of the valve is maintained. The positioning wires are then disconnected and the delivery system withdrawn. The system provides trackability in highly torturous anatomies, thanks to a unique outer sheath material that increases control of the valve during deployment. In addition, the low profile and flexible delivery system enable easy access and full visibility even in high-calcified anatomies.

“We’re pleased to provide physicians with this latest advance in TAVI procedural control,” said Dan Lemaitre, President and CEO of Direct Flow Medical. “The DirecTrack Delivery System provides all the features of our prior delivery system, but with significantly enhanced ergonomics and precision to assure the best possible clinical outcome.”

“I have had the opportunity to use every generation of the Direct Flow Medical delivery system since its inception. The new DirecTrack system is a major step forward in positioning control and smooth valve delivery,” said professor of cardiology Joachim Schofer, MD, of the Hamburg University Cardiovascular Center (Germany). “I’m impressed with the additional procedural efficiency gained, making it faster and easier to achieve an optimal outcome.”

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