CLINICAL OUTCOMES

Valiant Navion
Thoracic Stent Graft System

VALIANT NAVION™ THORACIC STENT GRAFT SYSTEM PIVOTAL STUDY

The Valiant Navion Thoracic Stent Graft System Pivotal Study was designed to evaluate the safety and effectiveness of the Valiant Navion thoracic stent graft in the treatment of fusiform thoracic aortic aneurysms, saccular aneurysms, and penetrating aortic ulcers of the descending thoracic aorta.

  • Prospective, multi-center, single-arm trial
  • 100 subjects enrolled: Minimum of 87 evaluable subjects required for 30-day primary endpoint analysis
  • 37 activated sites in North America & EU

MAIN PATIENT RESULTS AT 30 DAYS*

MAIN PATIENT RESULTS AT 30 DAYS

Challenging patient population*

Challenging patient population

Proximal configuration usage

Proximal configuration usage

Procedural results*

VALIANT NAVION™ THORACIC STENT GRAFT SYSTEM
PIVOTAL STUDY endpoints*

Primary Endpoint Results

               

Access and/or Deployment Failures; and/or
MDEs within 30 Days Post Index Procedure

2.3% (2/87 patients)

Breakdown of Primary Endpoint

 

Overall Event Rates within 30 Days

2.3% (2/87 patients)

   Vessel Access Failure

0.0% (0/87 patients)

   Deployment Failure

0.0% (0/87 patients)

   Major Device Effects (MDE)

2.3% (2/87 patients)

      Device-related Secondary Procedures

2.3% (2/87 patients)

      Device-related Mortality

1.1% (1/87 patients)

      Conversion to Open Surgery

0.0% (0/87 patients)

      Thoracic Aortic Aneurysm Rupture

  1.1% (1/87 patients)

Imaging Outcomes at 30-day Visit

 

Endoleaks

  
   Type I

1.2% (1/81 patients)
      Type Ia 1.2% (1/81 patients)

      Type Ib

 0.0% (0/81 patients)
      Type Ic

0.0% (0/81 patients)
   Type II 1.2% (1/81 patients)
   Type III 0.0% (0/81 patients)

   Type IV

0.0% (0/81 patients)

   Type V

0.0% (0/81 patients)

   Type Undetermined

0.0% (0/81 patients)

   Subjects with Endoleaks (any type)

2.5% (2/81 patients)

Through 30 Days

 

Paraplegia

0.0% (0/87 patients)

Paraparesis

0.0% (0/87 patients)

Reference
*Data on file at Medtronic, Valiant Navion CSR (or IFU for U.S.)
†Reported as closed web within the clinical study