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The pivotal trial† for Valiant Navion™ was designed to evaluate the safety and effectiveness of the Valiant Navion system in patients with a descending thoracic aortic aneurysm (DTAA) or penetrating atherosclerotic ulcer (PAU). The patients treated in the study represented a challenging patient cohort, with 40% female patients and 86.5% high thoracic aortic tortuosity.
(70/100)
(73/99)
(77/89)
(49/100)
Case study image courtesy of Dr. Nimesh Desai.
(73/100)
(27/100)
These data are very encouraging, especially as we consider the complex patient population enrolled in this study — many of whom were not previously considered candidates for endovascular repair.
Dr. Ali Azizzadeh, M.D. Director of Vascular Surgery; Vice Chair, Surgery; Associate Director, Heart Institute; Cedars Sinai Medical Center
There was 0.0% (0/75) type 1a endoleak at 1-year follow-up (1/94 type 1a endoleak at 1 month) and 94.8% freedom from secondary procedures through 1 year.
These outstanding results through 1 year further confirm that Valiant Navion is a safe and effective treatment option for all lesions of the descending thoracic aorta.
These results demonstrate the Medtronic commitment to lifesaving treatments backed by clinical data.
(49/100)
(100/100)
(0/75)
with Valiant Navion thoracic stent graft system
Secondary Endpoints at 1 Year |
|
---|---|
Endoleaks |
|
Type I | 4.0% (3/75) |
Type Ia | 0.0% (0/75) |
Type Ib |
4.0% (3/75) |
Type Ic | 0.0% (0/75) |
Type II | 2.7% (2/75) |
Type III | 0.0% (0/75) |
Type IV |
0.0% (0/75) |
Type V |
0.0% (0/75) |
Type Undetermined |
0.0% (0/75) |
Subjects with Endoleaks (any type) |
6.7% (5/75) |
(0/100)
(0/100)
(0/100)
Despite the challenging anatomic characteristics of the cohort, the low-profile delivery system had no incidences of access artery or deployment failures.1
Primary Endpoint Results |
|
---|---|
Access and/or Deployment Failures; and/or |
2.0% (2/100) |
Breakdown of Primary Endpoint |
|
Overall Event Rates within 30 Days |
2.0% (2/100) |
Vessel Access Failure |
0.0% (0/100) |
Deployment Failure |
0.0% (0/100) |
Major Device Effects (MDE) |
2.0% (2/100) |
Device-related Secondary Procedures |
2.0% (2/100) |
Device-related Mortality |
1.0% (1/100) |
Conversion to Open Surgery |
0.0% (0/100) |
Thoracic Aortic Aneurysm Rupture |
1.0% (1/100) |
Through 30 Days |
|
Paraplegia |
0.0% (0/100) |
Paraparesis |
0.0% (0/100) |
Choose from a complete portfolio of market-leading aortic vascular therapies to treat aortic disease.
Download CatalogCardioVascular Lifeline Customer Support
1-763-526-7890Orders
1-888-283-786824-hour Technical Support
1-763-514-4000Data on file at Medtronic, Valiant Navion CSR (or IFU for U.S.).
Global Clinical Program (NCT02652949, NCT02625324).
Reported as closed web within the clinical study.
Azizzadeh A, Desai N, Arko FR III, et al. Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. J Vasc Surg. November 2019;70(5):1399-1408.e1.