CLINICAL OUTCOMES Valiant Navion Thoracic Stent Graft System

Alert Indications, Safety, and Warnings

Quick links to study sections

Study design

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.

  • Prospective, multicenter, single-arm trial
  • 100 subjects enrolled across 37 sites across North America and Europe

Selected patient and vessel characteristics (n = 100)

ASA Class III/IV
70%

(70/100)

Severe access artery tortuosity
73.7%

(73/99)

High thoracic aorta tortuosity
86.5%

(77/89)

Percutaneous access
49%

(49/100)

  • USA: 72% 
  • Outside United States: 23%

Precase imaging and 3d recon
 rapidly enlarging dta — residual dissection    

Case study image courtesy of Dr. Nimesh Desai.

3D Recon rotating animation showing the steep arch of the anatomy in a type B aortic dissection

PROXIMAL CONFIGURATION USAGE

FreeFlo
73.0%

(73/100)

Valiant Navion FreeFlo thoracic stent graft on white background

CoveredSeal‡
27.0%

(27/100)

Valiant Navion CoveredSeal thoracic stent graft on white background

Study Results at 1 Year

Delivering strong 1-year results

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

Full cohort results through 1 year*

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.

Percutaneous access
49%

(49/100)

delivery deployment success
100%

(100/100)

Freedom from secondary procedures at 1 year
94.8%

Type 1A endoleak at 1 year
0.0%

(0/75)

you can confidently treat even more patients 

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)

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Secondary Endpoints at 30 Days

0 Access failures

(0/100)

0 deployment failures

(0/100)

0 conversions to open surgery

(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
MDEs within 30 Days Post-index Procedure

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)

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Additional Resources 

Aortic Catalog

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Contact Us

Contact Information

CardioVascular Lifeline Customer Support

1-763-526-7890
rs.cstechsupport@medtronic.com

Orders

1-888-283-7868
rs.cusvasorders@medtronic.com

24-hour Technical Support

1-763-514-4000
*

Data 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.

Reference

1

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.