Aortic stent grafts
Ovation iX Abdominal Stent Graft System
A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
Ovation iX Abdominal Stent Graft System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| Aortic Body | Outer Diameter 26 mm; Catheter Gauge 14 Fr | MR Conditional | Available |
| Aortic Body | Outer Diameter 29 mm; Catheter Gauge 14 Fr | MR Conditional | Available |
| Aortic Body | Outer Diameter 20 mm; Catheter Gauge 14 Fr | MR Conditional | Available |
| Aortic Body | Outer Diameter 34 mm; Catheter Gauge 15 Fr | MR Conditional | Available |
| Aortic Body | Outer Diameter 23 mm; Catheter Gauge 14 Fr | MR Conditional | Available |
FDA clearances
- PMA P120006 August 2013
Procedures that use aortic stent grafts
Frequently asked questions
What is Ovation iX Abdominal Stent Graft System used for?
A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
Who makes Ovation iX Abdominal Stent Graft System?
Ovation iX Abdominal Stent Graft System is made by Trivascular, Inc.. It is listed under aortic stent grafts (evar/tevar) in our device library.
What sizes does Ovation iX Abdominal Stent Graft System come in?
Sizes listed for Ovation iX Abdominal Stent Graft System: Outer Diameter: 20–34 mm; Catheter Gauge: 14–15 Fr. Confirm availability with the manufacturer's instructions for use.
Is Ovation iX Abdominal Stent Graft System MRI safe?
The FDA device database lists Ovation iX Abdominal Stent Graft System as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Ovation iX Abdominal Stent Graft System FDA cleared?
Ovation iX Abdominal Stent Graft System is covered by FDA submission P120006.
How do I contact a Trivascular, Inc. sales representative?
Trivascular, Inc. has not listed representatives on LA Vascular yet. Visit the Trivascular, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.