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Medtronic's Valiant Navion(TM) Thoracic Stent Graft System Receives FDA Approval for Aortic Diseases

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Medtronic's Valiant Navion(TM) Thoracic Stent Graft System Receives FDA Approval for Aortic Diseases

Shots:
  • The approval is based on 1EP analysis of 87 subjects involved in IDE study enrolling 37.9% female & 71.3% patients with systemic diseases- testing its safety and efficacy in TAA and PAU patients
  • Results: Acc. To FreeFlo- CoveredSeal configuration: no instances of access or deployment failures (74.7%- 25.3%); mean procedure and fluoroscopy times (88.7 ± 53.4/12.2 ± 8.8 mins); low rates of peri-operative mortality 2.3% & secondary procedures at 2.3%; Type Ia endoleaks 1.2%
  • Valiant Navion structure is based on Valiant Captivia system with improved performance- having CoveredSeal & FreeFlo configurations offering two graft options for patients with TAA- BTAI- PAU- IMH- TBAD
/ article | Ref: Medtronic | Image: Compelo

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