Heli-FX^™ EndoAnchor^™ system for EVAR and TEVAR procedures.

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Heli-FX EndoAnchor system including deflecting guide catheter with cassette containing EndoAnchors

Overview

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 anastomosis¹ and addresses concerns for future complications. ESAR has been shown to protect against neck dilatation,² minimize type Ia endoleaks,³and promote greater sac regression than EVAR alone.^4–5

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.

Heli-FX EndoAnchor components

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

Heli-FX guide
Heli-FX applier
EndoAnchor cassette (contains 10 EndoAnchor implants)

pdf Case planning clock (.pdf)

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

279KB

Product features

Reinforced seal. Redefined outcomes.^1,4–11

Prophylactic, therapeutic transmural fixation for the strength and stability of a surgical anastomosis^1,6
Enhanced proximal seal zone competency¹ and protection against neck dilatation²
Promotion of sac regression and demonstrated durability through five years^2-4

Therapeutic

Off-the-shelf treatment to treat intraoperative type Ia endoleaks
Off-the-shelf treatment for late type Ia endoleaks and migrated endografts
Evaluated and indicated for use 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 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
Radiopaque implants and markers on delivery system to aid with visualization
Low-profile delivery system
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.

Ordering information

EVAR ordering information

AAA components (mm)	Deflected tip reach (mm)	Recommended neck diameter (mm)	Working length (cm)	Outer diameter (Fr)	Model number
Heli-FX™ Guide, 22	22	18–28	62	16	SG-64
Heli-FX™ Guide, 28	28	28–32	62	16	HG-16-62-28
Heli-FX™ Applier and EndoAnchor™ Cassette (with 10 EndoAnchors)	—	—	86	12	SA-85

TEVAR ordering information

TAA components (mm)	Deflected tip reach (mm)	Recommended neck diameter (mm)	Working length (cm)	Outer diameter (Fr)	Model number
Heli-FX™ Guide, 22	22	18–28	90	18	HG-18-90-22
Heli-FX™ Guide, 32	32	28–38	90	18	HG-18-90-32
Heli-FX™ Guide, 42	42	38–42	90	18	HG-18-90-42
Heli-FX™ Applier and EndoAnchor™ Cassette (with 10 EndoAnchors)	—	—	114	12	HA-18-114

pdf EVAR & TEVAR ordering information (.pdf)

726KB

Additional resources

Aortic catalog

Choose from a complete portfolio of market-leading aortic vascular therapies to treat aneurysm disease.

Download catalog

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

References

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.

Tassiopoulos AK, Monastiriotis S, Jordan WD, Muhs BE, Ouriel K, De Vries JP. Predictors of early aortic neck dilatation after endovascular aneurysm repair with EndoAnchors. J Vasc Surg. 2017 Jul;66(1):45–52.

William D. Jordan, Jr., M.D. ”New developments from the ANCHOR registry: early 5 year prophylactic results”, presented at VEITH symposium; November 18th 2021; Orlando, Florida, USA

⁴

Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699–1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18. PMID: 29248241.

⁵

Reyes Valdivia A, Oikonomou K, Milner R. et al. The effect of EndoAnchors on aneurysm sac regression for patients treated with infrarenal endovascular repair with hostile neck anatomies: a propensity scored analysis. J Endovasc Ther. 2022 Oct 10:15266028221127839. doi: 10.1177/15266028221127839.

⁶

Schlösser FJV, de Vries JPPM, Chaudhuri A. Is it Time to Insert EndoAnchors into Routine EVAR? Eur J Vasc Endovasc Surg. April 2017;53(4):458–459.

⁷

Kouvelos GN, Antoniou G, Spanos K, Giannoukas A, Matsagkas M. Endovascular aneurysm repair in patients with a wide proximal aortic neck: a systematic review and meta-analysis of comparative studies. J Cardiovasc Surg (Torino). 2019 Apr;60(2):167–174. doi: 10.23736/S0021-9509.19.10869-5. Epub 2019 Jan 18. PMID: 30665285.

⁸

Laczynski DJ, Caputo FJ. Systematic review and meta-analysis of endovascular abdominal aortic repair in large diameter infrarenal necks. J Vasc Surg. 2021 Jul;74(1):309–315.e2. doi: 10.1016/j.jvs.2021.02.043. Epub 2021 Mar 17. PMID: 33722632.

⁹

Gargiulo M, Gallitto E, Wattez H. et al. Outcomes of endovascular aneurysm repair performed in abdominal aortic aneurysms with large infrarenal necks. J Vasc Surg. 2017 Oct;66(4):1065–1072. doi: 10.1016/j.jvs.2017.01.066. Epub 2017 May 3. PMID: 28478020.

¹⁰

McFarland G, Tran K, Virgin-Downey W. et al. Infrarenal endovascular aneurysm repair with large device (34- to 36-mm) diameters is associated with higher risk of proximal fixation failure. J Vasc Surg. 2019 Feb;69(2):385–393. doi: 10.1016/j.jvs.2018.02.054. Epub 2018 Jun 28. PMID: 30686336.

¹¹

Heli-FX™ EndoAnchor™ system clinical evidence.

Heli-FX™ EndoAnchor™ system for EVAR and TEVAR procedures.