EVAR Instructions for Use (IFU): What They Mean ... - VascularWeb

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Instructions for Use (IFU) Guidant Ancure Medtronic AneuRX Gore Excluder Cook Zenith Gore Excluder Low Permeability Endologix Powerlink Cook Zenith Enlarged Neck Medtronic Talent Endologix Enlarged Neck Gore Excluder Enlarged Neck Year of Release 1999 1999 2002 2003 2004 2004 2006 2008 2009 2009 Neck Diameter (mm) 18-26 18-25 19-26 18-28 19-26 18-26 18-32 18-32 18-32 19-29 Neck Length (mm) ≥15 ≥10* ≥15 ≥15 ≥15 ≥15 ≥15 ≥10 ≥15 ≥15 Neck Angle (degrees) NS ≤45 ≤60 ≤45 ≤60 ≤60 ≤60 ≤60 ≤60 ≤60 Iliac Fixation Length (mm) ≥20 NS ≥10 ≥15 ≥10 ≥15 ≥15 ≥15 ≥15 ≥10 Iliac Diameter (mm)
Instructions for Use (IFU)-Derivation • Target IFU parameters determined • Prototype device designed • Bench top testing – Mock configurations in models – Fatigue testing (10 year simulation) • Clinical testing – Phase 1 – Phase 2
Page 1 and 2: EVAR Instructions for Use (IFU): Wh
Page 3 and 4: Baseline aortic anatomy is a key de
Page 5 and 6: Endovascular Candidacy 32 mm diam N
Page 7 and 8: EVAR in 2004 Rupture 2/10/2012 Aort
Page 9: In the United States, >70% of elect
Page 13 and 14: IFU-Implementation Post Approval
Page 15 and 16: 565 patients classified according t
Page 17 and 18: 258 patients classified according t
Page 19 and 20: Goals: To analyze a large, multicen
Page 21 and 22: Research Design and Methods • Dat
Page 23 and 24: Instructions for Use (IFU) • IFU
Page 25 and 26: Results—Baseline Characteristics
Page 27 and 28: Results—Time Trends Year 1999-200
Page 29 and 30: FREEDOM FROM SAC ENLARGEMENT Outsid
Page 31 and 32: FREEDOM FROM SAC ENLARGEMENT OP DAT
Page 33 and 34: Risk Factors: •Aortic Neck Diamet
Page 35 and 36: Discussion • Aortic sac enlargeme
Page 37 and 38: Conclusions • Liberalization of t
Page 39 and 40: SVS Postgraduate Session • Intern

EVAR Instructions for Use (IFU): What They Mean ... - VascularWeb

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