3
1.
Device Description
The TriVascular Ovation™ Abdominal Stent Graft System is an endovascular device
delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The
stent graft is designed to reline the diseased vasculature, providing an alternate
endovascular blood conduit for isolating the aneurysm from the high pressure flow of
blood, thereby reducing or eliminating the risk of rupture. The stent graft is a modular
configuration comprised of an aortic body section, two iliac limbs, and iliac
extensions as required (Figure 1).
The TriVascular Ovation Abdominal Stent Graft System includes:
•
An Aortic Body Stent Graft and delivery catheter
•
Two Iliac Limb Stent Grafts and delivery catheter
•
Iliac Extension Stent Grafts and delivery catheter, as required
•
A Fill Polymer Kit
•
An Autoinjector
The aortic section is comprised of a proximal stent for suprarenal fixation and a low-
permeability PTFE graft. The stent is designed with integral anchors to enable
fixation to the aortic wall. For delivery, the stent is in a compressed state within the
catheter. When released from the compressed state, the stent expands to engage
the vessel wall. The nitinol stent is radiopaque and the implant contains radiopaque
markers adjacent to the proximal graft edge. These radiopaque markers serve as
positioning aids during placement of the device and allow the implant to be located
so that it can be positioned to not obstruct the renal arteries. To seal the proximal
end of the graft and to provide support into which the iliac limbs are deployed, the
graft body contains a network of inflatable rings that are filled with a liquid polymer
that solidifies during the deployment procedure. The graft has a fill port that connects
the fill network of the graft to the delivery catheter.
The iliac limbs and extensions are comprised of a nitinol stent encapsulated in PTFE.
The limbs are deployed into the limb section of the aortic body. Radiopaque markers
allow the physician to visualize the appropriate iliac limb - aortic body overlap or iliac
extension – iliac limb overlap during a catheter-based deployment. Stent radial force
provides both fixation and sealing of the interface between the aortic body and each
iliac limb, between the iliac limb and iliac extension, and between the iliac
limb/extension and its landing zone in the iliac artery.
Figure 1.
Schematic of Deployed TriVascular Ovation Abdominal Stent Graft
1.1. Delivery System
To facilitate device introduction into the access vessel, the aortic body, the iliac limbs,
and the iliac extensions are preloaded into low-profile delivery catheters (14F–15F
OD, 13F–15F OD, and 13F – 14F OD respectively, Figure 2 and Figure 3). The
aortic body is deployed via the aortic body delivery catheter. The aortic body delivery
catheter has a lumen that allows for the use of a guidewire to help deliver the stent
graft to the deployment site.
During 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 (supplied).
