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Device | Endurant II/IIs Stent Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S063 |
Date Received | 04/03/2017 |
Decision Date | 09/29/2017 |
Product Code |
MIH |
Docket Number | 17M-5997 |
Notice Date | 10/05/2017 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01534819
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the expansion of the indications for use of the Endurant II/Endurant IIs Stent Graft System to include the treatment of infrarenal abdominal aortic aneurysms having neck lengths >= 4 mm and < 10 mm (“short necks”), when used in conjunction with the Heli-FX EndoAnchor System. The Endurant II/Endurant IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX EndoAnchor System when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (>= 4 mm and < 10 mm) infrarenal necks. The Endurant II aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/Endurant IIs Stent Graft System is indicated for use in patients with the following characteristics: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; 2) Proximal neck length of: >=10 mm or >= 4 and <10 mm, when used in conjunction with the Heli-FX EndoAnchor System (bifurcated stent graft only) (Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter); 3) Infrarenal neck angulation of <= 60°; 4) Aortic neck diameters with a range of 19 to 32 mm; 5) Distal fixation length(s) of >= 15 mm; 6) Iliac diameters with a range of 8 to 25 mm; and 7) Morphology suitable for aneurysm repair. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |