Aortic accessories

Heli-FX™ EndoAnchor™ system

<p>The Heli-FX™ EndoAnchor™ system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery.</p>

Features

ESAR with the Heli-FX™ EndoAnchor™ system

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

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 components of the Heli-FX™ EndoAnchor™ system.

  1. Heli-FX™ guide
  2. Heli-FX™ applier
  3. EndoAnchor™ cassette (contains 10 EndoAnchor™ implants)
This is the Heli-FX™ EndoAnchor™ system with the handle and cassette image in a three-piece component.

Product details

Reinforced seal. Redefined outcomes.1,4–11

  • Prophylactic, therapeutic transmural fixation for the strength and stability of a surgical anastomosis1,6
  • Enhanced proximal seal zone competency1 and protection against neck dilatation2
  • Promotion of sac regression and demonstrated durability through five years2–4

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.

Risks may include failure to prevent/correct type I endoleaks, migration, sac enlargement. Visit website to learn more and for complete risk information.

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 Ia 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

Ordering information

EVAR ordering information

Item number AAA components (mm) Deflected tip reach (mm) Recommended neck diameter (mm) Working length (cm) Outer diameter (Fr)
SG-64 Heli-FX™ guide, 22 22 18–28 62 16
HG-16-62-28 Heli-FX™ guide, 28 28 28–32 62 16
SA-85 Heli-FX™ applier and EndoAnchor™ cassette (with 10 EndoAnchors) 86 12
EC-05 Ancillary EndoAnchor™ cassette (w/4 EndoAnchor™ implants)


TEVAR ordering information

Item number AAA components (mm) Deflected tip reach (mm) Recommended neck diameter (mm) Working length (cm) Outer diameter (Fr)
HG-18-90-22 Heli-FX™ guide, 22 22 18–28 90 18
HG-18-90-32 Heli-FX™ guide, 32 32 28–38 90 18
HG-18-90-42 Heli-FX™ guide, 42 42 38–42 90 18
HA-18-114 Heli-FX™ applier and EndoAnchor™ cassette (with 10 EndoAnchors) 114 12
EC-05 Ancillary EndoAnchor™ cassette (w/4 EndoAnchor™ implants)

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

  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. 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.
  3. 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Heli-FX™ EndoAnchor™ system clinical evidence.