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Heli-FX EndoAnchor System

EVAR and TEVAR Procedures

  • Heli-FX EndoAnchor System

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 anastomosis and addresses concerns for future complications. One year data shows decreased neck dilatation, decreased Type Ia endoleak rates, and a significant increase in sac regression.1

U.S. 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.

Features

Enhance Outcomes and Durability*

  • Helical EndoAnchor implants provide the stability of a surgical anastomosis.2
  • Customized placement addresses patient-specific needs.
  • Tailored seal and fixation applies to EVAR and TEVAR cases.

Maximize Outcomes in Complex Cases

  • Safe and effective treatment of more complex anatomies.
  • Enhanced durability to address concerns for future complications.
  • Rapid bailout for Type Ia endoleaks.
Heli-FX EndoAnchor System in Place

Heli-FX EndoAnchor System in Place
Enhance durability to the level of a surgical anastomosis

EndoAnchor Design

EndoAnchor Implant Design
Helical technology of the Heli-FX EndoAnchor implant


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Graft Compatibility   

The Heli-FX EndoAnchor system has been evaluated and determined to be compatible with the following AAA endografts:

  • Medtronic Endurant™ stent graft systems
  • Medtronic Talent™ stent graft system
  • Medtronic AneuRX™ stent graft system
  • Cook Zenith™* stent grafts
  • Gore Excluder™* stent grafts
  • Jotec E-vita™* stent grafts

The Heli-FX Thoracic EndoAnchor system has been evaluated and determined to be compatible with the following TAA grafts:

The Heli-FX EndoAnchor implant is contraindicated with Endologix AFX™* stent grafts and does not have established compatibility with other stent grafts not listed above.

Clinician Experiences

Clinician Experiences with the Heli-FX EndoAnchor System

Leading clinicians discuss their use of EndoAnchor implants in a variety of cases.
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Case of a Ruptured Aneurysm

Dr. Bart Muhs recalls his first use of Heli-FX EndoAnchor implants and why he continues to use them regularly.
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Using the Heli-FX EndoAnchor System in Challenging Anatomies

Dr. Jean Panneton discusses EndoAnchor implant use in patients with a high ASG score and why he has deployed more than a thousand to date.
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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

 

pdf Case Planning Clock (.pdf)

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

673KB

Case Planning Clock (OUS)

Heli-FX EndoAnchor Components
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 Components
pdf Heli-FX EndoAnchor System Case Book (.pdf)

View a variety of AAA and TAA cases where EndoAnchor implants are used to enhance outcomes and durability.

3.3MB

Heli-FX EndoAnchor System Case Book

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 877-526-7890.

Model Specifications

EVAR ORDERING INFORMATION

AAA Components
(mm)		 Deflected
Tip Reach
(mm)		 Recommended
Neck Diameter
(mm)		 Working
Length
(cm)		 Outer
Diameter
(F)		 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
(w/ 10 EndoAnchors)		 NA NA 86 12 SA-85

 

TEVAR ORDERING INFORMATION

TAA Components
(mm)		 Deflected
Tip Reach
(mm)		 Recommended
Neck Diameter
(mm)		 Working
Length
(cm)		 Outer
Diameter
(F)		 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
(w/ 10 EndoAnchors)		 NA NA 114 12 HA-18-114

 

*

Bench test data on file at Medtronic. Test data not indicative of clinical performance. 

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

1

One Year Propensity Matched Comparison of EVAR in Hostile Neck Patients with and without EndoAnchors, presentation by Bart Muhs, MD, Veith 2016. Corelab was used to measure aneurysm diameters: dilatation was defined as the difference between 1-month and 12-month aortic neck diameters post-procedure.

2

Melas N, et al. Helical EndoAnchor Implants Provide the Stability of a Surgical Anastomosis. J Vasc Surg. 2012;55(6):1726-1733.