The Hydra aortic valve stent frame is made of nitinol and the leaflets are cut out of bovine pericardium. It is designed for compatibility with the native anatomy for percutaneous replacement procedures. The three tentacles (antenna) on the stent frame provide flexible anchors at the outflow which provides conformability to the shape of the aorta. The inflow section of the frame exerts a higher but optimum radial force to ensure secure attachment to the annulus. The bio-prosthesis is made from pericardium and sutured around the stent frame in a three leaflet configuration. The leaflets are designed to function in various shape or dimensions. The bovine pericardium used is approved for human use.
The catheter is compatible with a 0.035 in (0.889 mm) guidewire. The distal end of the system features a radiopaque tip. The bioprothesis is crimped into a protective 18F sheath at the distal end. The handle is located on the proximal end of the catheter and is used to load and deploy the bioprosthesis. The handle includes a turning knob to open and close the capsule and to facilitate precise bioprosthesis placement. The knob turns clockwise to retract the delivery catheter for deployment and counterclockwise to advance the delivery catheter. The catheter (Model HYDRA18F) is the same for the three models of the bioprothesis. The loading system compresses the bio-prosthesis into the delivery catheter thus preventing trauma to the valve leaflets. It is a single operator system, easy to load. One loading system is used to load all valve sizes.
|Diameter ( ϕ A) mm||22||26||30|
|Diameter ( ϕ B) mm||39||43||47|
|Height (H) mm||55||53||51|
|Sealing Skirt Height (C) mm||12||13||14|
|FirstMarker (D) mm||5||6||7|
|SecondMarker (E) mm||15||18 mm||21 mm|
|Annulus Size||18 to 20||20 to 24||24 to 27|