Medtronic’s Valiant Navion(TM) Thoracic Stent Graft System Receives FDA Approval for Aortic Diseases
Medtronic Reports Results of Symplicity Renal Denervation System in Two Studies for Hypertensive Heart 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
Click here to read full press release/ article | Ref: Medtronic | Image: Compelo