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WestinghouseOvation EX06098 Brand New Module

Introduction

To facilitate device introduction into the access vessel, the aortic body, the iliac limbs, and the iliac extensions are preloaded into delivery catheters as illustrated in Figure 3 – Figure 5. The delivery catheters each have a lumen for use with a guidewire to facilitate access and deployment. The inner catheter of the Ovation iX stent graft delivery systems can be withdrawn through the outer sheath, with the outer sheath remaining in the vasculature to facilitate the introduction of ancillary devices.

The aortic body delivery system includes an integrated crossover lumen as an option to facilitate guidewire access. The aortic body is deployed via the aortic body delivery catheter which has a connection to the distal legs of the aortic body. During aortic body stent graft deployment, the device is first positioned and the sheath is retracted. The proximal stent is then deployed using stent release knobs on the handle. The fill polymer is then delivered through the fill connector port using the Autoinjector. The contralateral and ipsilateral iliac limbs are each deployed via iliac limb delivery catheters. After deployment of the aortic body, a guidewire is placed from the contralateral access site into the contralateral distal leg of the aortic body; the integrated crossover lumen can be utilized to facilitate the process. The contralateral iliac limb is advanced into position and deployed into the aortic body leg by retracting the catheter sheath with the catheter in the appropriate position.

The contralateral limb delivery catheter is then used as an integral sheath (as described above) or withdrawn from the vasculature. After the fill polymer cures within the sealing rings, the aortic body delivery catheter is detached from the fill port of the graft and is used as an integral sheath (as described above) or withdrawn from the vasculature. The ipsilateral iliac limb delivery catheter is advanced over the ipsilateral guidewire and deployed using the method described above for the contralateral limb. The ipsilateral limb delivery catheter is then used as an integral sheath (as described above) or withdrawn from the vasculature.

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