Instructions for Use Aorfix™ AAA Flexible Stent Graft System with IntelliFlex™ Low Profile Delivery System

The Aorfix™ Abdominal Aortic Aneurysm (AAA) Flexible Stent Graft System is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms. When placed within the aneurysm, the Aorfix AAA Flexible Stent Graft System creates an internal bypass of the aneurysm to reduce the risk of rupture. The Aorfix AAA Flexible Stent Graft System is a modular system where each component comprises: an implantable stent graft (Aorfix Stent Graft) and a disposable delivery system (IntelliFlex™ Low Profile Delivery System). The stent graft is a two-piece system consisting of 1) a main...

Main Body The main body stent graft has three sections; the body top, the ipsilateral leg and the contralateral socket as described below. It is available with proximal diameters from 24mm to 31mm. 1.2.1 The key features of the body top are shown in Figure 2. Hooks are positioned at four locations spaced 90° apart around the circumference at the proximal end and are designed to resist migration. A total of four pairs of hooks are used in Aorfix™. The reinforcing wire is in ring form, rather than a traditional zig-zag or diamond mesh stent. At the proximal end, the wire rings are placed closer...

Figure 3 Shape of Nitinol Wire Used to Form Stent Rings Figure 4 Lateral View of a 24mm Stent Graft Once Deployed, Showing the Fishmouth Shape. All ipsilateral legs have a standard 12mm internal diameter at their proximal ends. The distal ends are flared on legs with distal diameters larger than 12mm and taper down for the 10mm distal diameter. The range of sizes for the distal diameter of this implant is from 10mm to 20mm in 2mm steps. There are no hooks on the leg. All leg components in the Aorfix™ range are reinforced with Nitinol wire that is wound in a continuous helical shape.

Contralateral Socket The socket also has a standard 12mm internal diameter and has an oblique distal end. There is a proximal radiopaque wire ring as well as the distal radiopaque ring to provide a visual guide to the clinician when cannulating the contralateral socket. Note that the oblique entrance to the contralateral socket is not present in any of the 81mm long main body implants as shown in Figure 5. Figure 5 Contralateral Sockets 25mm 15mm Contralateral Socket used on Body lengths: 96mm, 111mm and 126mm Contralateral Socket used on Body lengths: All 81mm All contralateral legs have a standard...

Figure 6 Dimensions of a Contralateral Plug-in Leg Proximal and Distal Extender Components All extension pieces, shown in Figure 7, have the same diameter at both ends and have radiopaque wire rings at the proximal and distal openings to aid visualization. Like the main body, the proximal extension pieces have hooks at the proximal end, the same design of nitinol rings, and radiopaque wire along the seam. They are available in diameters 24mm through 31mm. Shown in Figure 8, the proximal extender also has a fishmouth shape which should be deployed with the same orientation as the fishmouth of...

Figure 7 Proximal and Distal Extension Pieces Proximal Extender Distal Extender Figure 8 Use of Proximal Extender with Main Bifurcated Graft Aorto-Uni-Iliac Converter (AUI Converter) A ‘bail-out’ AUI converter is available as part of the Aorfix™ AAA Flexible Stent Graft System. The AUI Converter is supplied on the Aorflex™ delivery system and has its own IFU specific to that device.

IntelliFlex™ Low Profile Main Body Delivery System Figure 9 IntelliFlex Low Profile Main Body Delivery System The main components of the IntelliFlex Low Profile delivery system are shown above in Figure 9 and are listed below in Table 1. The IntelliFlex Low Profile main body delivery system includes an exchange sheath. After deployment and release of the stent-graft, the Graft Deployment Mechanism can be removed from the delivery system, leaving in place an 18Fr endovascular sheath with hemostatic valve and flushing port. Table 1 Components of the Main Body Delivery System Diagram Part Stent...

Diagram Part Radiopaque Marker Band This band shows the position of the tip of the sheath under X-ray so that the progress of deployment can be seen. Proximal Handle The handle is firmly attached to, and stabilizes the delivery system while the controls on the delivery system are operated. Sheath Control This controls retraction of the sheath, in a counter clockwise motion. Orientation Mark The orientation mark is the origin of the exchange sheath flushing port, this indicates the anterior face of the implant. This cover slides toward the delivery system’s tip to give access to the Y-mechanism...

IntelliFlex™ Low Profile Contralateral Delivery System Figure 10 IntelliFlex LP Contralateral Leg Delivery System The main components of the IntelliFlex Low Profile contralateral delivery system are shown above in Figure 10 and are listed below in Table 2. The IntelliFlex Low Profile contralateral delivery system includes an exchange sheath. After deployment and release of the stent-graft, the graft deployment mechanism can be removed from the delivery system to leave in place a 16Fr endovascular sheath with hemostatic valve and flushing port.

Table 2 Components of the IntelliFlex™ Low Profile Contralateral Delivery System Diagram Label Stent Graft The stent graft is compressed within the sheath. Its proximal and distal ends can be clearly seen. Braided Sheath The double braided sheath has a 16Fr lumen and contains the stent graft and attachments to it. The sheath is translucent and allows the key parts of the stent graft to be seen through it. It has a hydrophilic coating on its outer surface. Radiopaque Marker Band This band shows the position of the tip of the sheath under X-ray so that the progress of deployment can be seen. Proximal...

Ancillary Components Delivery Systems The proximal extender has the same delivery system as the main body implant. Distal extender pieces have the same delivery system as the contralateral leg. The AUI Converter is supplied on the Aorflex™ delivery system and has its own IFU specific to that device. INDICATIONS FOR USE Aorfix™ is indicated for: • the endovascular treatment of infra-renal abdominal aortic, iliac and abdominal aortoiliac aneurysms with peri-renal neck angles up to and including 90 degrees, including: o Aortic neck landing zone diameters with a range of 19mm to 29 mm o Common iliac...