9
6.
Patient Selection and Treatment
6.1. Individualization of Treatment
The TriVascular Ovation Abdominal Stent Graft System must be selected in a size
appropriate to the patient’s anatomy. The sizing options for the device are detailed in
Table 1 Patient Sizing Information.
Table 1.
Patient Sizing Information
Aortic Body
Iliac Limb / Extension
Stent Graft
Diameter, mm
Aortic ID,
mm*
Stent Graft
Diameter, mm
Iliac ID,
mm
34
27-30
22
18-20
29
24-26
18
16-17
26
21-23
16
14-15
23
18-20
14
12-13
20
16-17
12
10-11
10
8-9
* At the intended proximal sealing ring location. Ensure adequate oversizing of the
proximal stent at its anchoring location.
The recommended overall length of the deployed, implanted system should extend
from the lowest renal artery to just above the internal iliac bifurcation. If pre-operative
case planning measurements are not certain, ensure that all potential stent graft
lengths and diameters are available to complete the procedure.
Considerations for patient selection include but are not limited to:
•
Patient’s age and life expectancy
•
Co-morbidities (e.g., cardiac, pulmonary or renal insufficiency prior to
surgery, morbid obesity)
•
Patient morphologic suitability for endovascular repair
•
Patient’s suitability for open surgical repair
During the case planning process, TriVascular may consult with physicians in their
efforts to determine appropriate stent graft sizing.
6.2. Specific Patient Populations
The Ovation Abdominal Stent Graft System has not been evaluated in patients who:
•
Are pregnant or nursing;
•
Have traumatic aortic injury;
•
Have suprarenal or thoraco-abdominal aneurysms;
•
Have acutely ruptured aneurysms or aneurysms pending rupture;
•
Have hypercoagulability;
•
Have ilio-femoral, thoracic or inflammatory aneurysms;
•
Have juxtrarenal AAA;
•
Have pararenal AAA;
•
Have mesenteric artery occlusive disease;
•
Have connective tissue disorder.
7.
Patient Counseling Information
Prior to treatment, the physician should review with the patient the risks and benefits
of this endovascular procedure, including:
•
Risks, benefits and differences of open surgical repair;
•
Risks, benefits and differences of endovascular repair;
