Alert Indications, Safety, and Warnings

Heli-FX™ EndoAnchor™ system for endovascular aneurysm repair (EVAR) and thoracic endovascular aortic repair (TEVAR) procedures

Provide transmural fixation of the endograft to the aorta with the Heli-FX EndoAnchor system. The Heli-FX EndoAnchor system enhances durability to the level of a surgical anastomosis and addresses concerns for future complications.

See clinical data
Heli-FX EndoAnchor system including deflecting guide catheter with cassette containing EndoAnchors
Alert Indications, Safety, and Warnings

Overview

ESAR with the  Heli-FX EndoAnchor system

Learn about the benefits of ESAR and the key elements of deployment.

Indications

The Heli-FX EndoAnchor system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX EndoAnchor system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor implant may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

Product Details

We offer two independent securement systems for EVAR and TEVAR procedures — the Heli-FX EndoAnchor system and the Heli-FX Thoracic EndoAnchor system.

INDICATIONS

The Heli-FX™ EndoAnchor™ System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery.  The Heli-FX EndoAnchor System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.  The EndoAnchor implant may be implanted at the time of the initial endograft placement, or during a secondary (i.e. repair) procedure.

Heli-FX EndoAnchor components

There are three delivery components of the Heli-FX EndoAnchor system.

  1. Heli-FX guide
  2. Heli-FX applier
  3. EndoAnchor cassette (contains 10 EndoAnchor implants)
Heli-FX EndoAnchor system including deflecting guide catheter with cassette containing EndoAnchors
pdf Case planning clock (.pdf)

Use this tool to plan the C-arm rotation angles needed to position the EndoAnchor implants.

284KB

Document thumbnail

Product features

Reinforced seal for enhanced outcomes

  • Prophylactic, therapeutic transmural fixation for the strength and stability of a surgical anastomosis1
  • Enhanced proximal seal zone competency and protection against neck dilatation
  • Promotions of sac regression and demonstrated durability through five years2,3

Therapeutic

  • Off-the-shelf treatment to treat intraoperative type Ia endoleaks
  • Off-the-shelf treatment for late type Ia endoleaks and migrated endografts
  • Enhanced clinical utility through applicability with multiple endografts†

The EndoAnchor implant and Heli-FX EndoAnchor system have been evaluated via in vitro testing and determined to be compatible with the Cook Zenith™*, Cook Zenith TX2™*, Gore Excluder™*, Gore TAG™*, Medtronic AneuRx™, Medtronic Endurant™, Medtronic Talent™ AAA, Medtronic Talent™ TAA, Medtronic Valiant™ Xcelerant™, Medtronic Valiant™ Captivia™, and Medtronic Valiant Navion™ endografts.

Conical tip

Helical shape

Proximal crossbar

Neck dilatation challenges and EndoAnchor design features

Learn how ESAR with the Heli-FX EndoAnchor system reinforces the proximal seal and protects against neck dilatation to minimize both transient and persistent type la endoleaks.

Delivery and deployment

Clinician-directed deployment with the Heli-FX EndoAnchor system locks the endograft to the aorta.

  • Motorized, intuitive controls for precise placement of EndoAnchor implants
  • Excellent system and EndoAnchor implant radiopacity
  • Low-profile delivery system for precise and fast deployment of the implants
  • Different deflection tip lengths to address varying neck diameters

Manuals and technical guides

Instructions for use

Find this technical manual in the Medtronic manual library, in the product labeling supplied with each device, or by calling 1-877-526-7890.

Ordering information

pdf EVAR & TEVAR ordering information (.pdf)

732KB

Document thumbnail

Additional resources

Related pages

Connect with us

Sign up for updates and information.

Sign up

Discover education on Medtronic Academy

View presentations and videos and find other educational resources.

Discover education
*

™Third-party brands are trademarks of their respective owners.

†

Cook Zenith, Cook Zenith TX2, Gore Excluder, Gore TAG, Medtronic AneuRx, Medtronic Endurant, Medtronic Talent AAA, Medtronic Talent TAA, Medtronic Valiant Xcelerant, Medtronic Valiant Captivia, and Medtronic Valiant Navion endografts.

References

1

Melas N, Perdikides T, Saratzis A, Saratzis N, Kiskinis D, Deaton DH. Helical EndoStaples enhance endograft fixation in an experimental model using human cadaveric aortas. J Vasc Surg. June 2012;55(6):1726-1733.

2

ANCHOR five-year primary arm. 2020 data cut. Medtronic data on file.

3

Muhs BE, Jordan W, Ouriel K, et al. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. June 2018;67(6):1699-1707.