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The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels. When used in its indications for use, it is a low-permissive, over-the-wire, single-use device comprised of two elongated non-compliant nylon balloons that are attached to and within a nitinol support frame. The two elongated balloons are constrained in a zigzag arrangement by the nitinol support frame. Upon inflation, this configuration enables expansion of the device head through balloon straightening, to assist the dilatation of self-expanding endoprostheses in large diameter vessels. Expansion of the zig-zag balloon configuration creates a central orifice permitting maintained hemodynamic flow during the molding procedure. The inflation lumen is 9 Fr and is made of PEBAX 72D. A co-axial PEBAX 72D guidewire lumen runs through the inflation lumen and device head and terminates into a distal polycarbonate tip. Two platinum-iridium markers provide angiographic visualization of the distal and proximal balloon edges to facilitate intravascular balloon placement prior to inflation. The catheter has a working length of 110 cm and it connects proximally to a standard Y-connector at the proximal end. The Y-connector allows for separation of two lumens - an angled luer-lock hub to inflate and deflate the balloon and a straight luer-lock hub which accepts a 0.035" guidewire. The device is deflated and inserted over the guidewire through the hemostasis valve of a transfemoral introducer sheath.