The Procedure

Procedure step 1

Delivery

The valve is delivered through a flexible, 18 French sheath, which ensures excellent trackability and minimizes vascular complications. The 18 French sheath is used for all valve sizes.

Procedure step 2

Deployment

The valve is deployed using saline/contrast pressurized to 12 atmospheres, which is delivered to the rings through hollow positioning wires. Following initial expansion, the valve remains fully competent throughout the procedure.

Procedure step 3

Assessment

Once the valve is fully deployed in the annulus, a complete assessment of hemodynamic performance can be performed.

Procedure step 4

Repositioning

By de-pressurizing either ring using a standard endoflator, the valve can be repositioned by manipulating the positioning wires. Repositioning and full hemodynamic assessment can be performed repeatedly if necessary.

Procedure step 5

Implantation

When the valve is optimally placed, saline/contrast 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 The positioning wires are then disconnected and the delivery system withdrawn.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 information on this site is only intended for health care providers in certain markets outside the United States (US) where the Direct Flow Medical Trancatheter Aortic Valve Replacement System is approved for use as indicated by the instructions for use. The information on this page is not intended for health care providers in the US or US health care institutions as this site contains information about a product that is limited by US law to investigational use.

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