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EUROPEAN Device Guide / Endograft Fixation Systems

Company Name Product Name Components Sizes Comments CE Mark Indications
Medtronic Heli-FX EndoAnchor System Ancillary EndoAnchor Cassette (contains five EndoAnchors) EndoAnchor implants are 3-mm diameter X 4.5-mm length helix shape, with 0.5-mm wire thickness Provides additional EndoAnchor implants to supplement independent transmural sealing and fixation of an endograft to the aortic wall Indicated for use in patients whose endografts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion; evaluated via in vitro testing and determined to be compatible with the Cook Zenith, Cook Zenith TX2, Gore Excluder, Gore TAG, Jotec E-vita, Medtronic AneuRx, Medtronic Endurant, Medtronic Valiant and Medtronic Talent endografts; use with other endografts has not been evaluated
Medtronic Heli-FX EndoAnchor System Heli-FX Applier with EndoAnchor Cassette (contains 10 EndoAnchors) 12-F OD; 86-cm working length Battery-operated delivery system with two-stage EndoAnchor deployment with repositioning capability; packaged with an EndoAnchor cassette (includes 10 EndoAnchor implants); EndoAnchor implants are 3-mm diameter X 4.5-mm length helix shape, with 0.5-mm wire thickness Indicated for use in patients whose endografts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion; evaluated via in vitro testing and determined to be compatible with the Cook Zenith, Cook Zenith TX2, Gore Excluder, Gore TAG, Jotec E-vita, Medtronic AneuRx, Medtronic Endurant, Medtronic Valiant and Medtronic Talent endografts; use with other endografts has not been evaluated
Medtronic Heli-FX EndoAnchor System Heli-FX Guide Deflecting tip length: 22, 28 mm; 16-F OD; 62-cm working length; 0.035-inch wire compatible Deflecting guide catheter used to position Heli-FX Applier to EndoAnchor implants Indicated for use in patients whose endografts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion; evaluated via in vitro testing and determined to be compatible with the Cook Zenith, Cook Zenith TX2, Gore Excluder, Gore TAG, Jotec E-vita, Medtronic AneuRx, Medtronic Endurant, Medtronic Valiant and Medtronic Talent endografts; use with other endografts has not been evaluated

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