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US Device Guide / Endograft Fixation Systems

Company Name Product Name Components Sizes Description US FDA Indicated Use
Medtronic Heli-FX EndoAnchor System Ancillary EndoAnchor Cassette (contains five EndoAnchors) 0.5-mm round wire; 3-mm diameter X 4.5-mm length helix Implants are designed to provide 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, Gore Excluder, Medtronic AneuRx, Medtronic Endurant, and Medtronic Talent AAA endografts; use with other endografts has not been evaluated
Medtronic Heli-FX EndoAnchor System Heli-FX Guide Deflecting tip lengths: 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 implant EndoAnchors 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, Gore Excluder, Medtronic AneuRx, Medtronic Endurant, and Medtronic Talent AAA 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 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, Gore Excluder, Medtronic AneuRx, Medtronic Endurant, and Medtronic Talent AAA endografts; use with other endografts has not been evaluated

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