Clinical Outcomes Heli-FX™ EndoAnchor™ System

Alert Important Safety Information

ANCHOR Registry and publications

Wide neck cohort (n = 72)
Primary AAA arm (n = 771)
Revision AAA arm (n = 261)
Short neck cohort (n = 70)
Journal articles

Expand All

Wide neck cohort (n = 72)

Wide proximal aortic necks experience suboptimal outcomes after standard EVAR.

Wide necks^† are:

6.7x more likely to have type Ia endoleak (p = 0.001)
10x more likely to have sac expansion (p = 0.009)
5.1x more likely to rupture (p = 0.01)

(N = 6,602 f/u ranged from 2.7 years (mean) to 3.9 years)¹

ESAR in wide necks: Reinforced seal, redefined outcomes.

When compared to wide necks in literature at similar time intervals, patients who received ESAR with the Heli-FX EndoAnchor system at the index procedure experienced better outcomes.

ANCHOR wide neck data

ESAR reinforces and protects the proximal seal, leading to better outcomes in wide necks. View data on wide necks from literature compared to the three-year wide neck results from the ANCHOR Registry.

ANCHOR Registry wide neck cohort three-year data (N = 72)²

(Wide necks ≥ 28 mm and ≤ 32 mm
Mean neck diameter 29.5 mm)

98.5% three-year FF type Ia endoleak

(One patient presented with a type Ia at their 30-day follow-up, self-resolved)
100% three-year FF secondary procedures to treat type Ia
100% three-year FF migration
100% three-year FF rupture
91.3% (21/23)^‡ sacs regressing/stable at three years
60.9% (14/23)^‡ sac regression at three years

Learn more about ESAR

The relevance of ANCHOR Registry wide neck data

Hear from Professor Michel Reijnen on the importance of the ANCHOR three-year wide neck data.

Using the ANCHOR Registry to help treat patients

Dr. William Jordan Jr. discusses the ANCHOR Registry and how it captures real-world usage and long-term outcomes of EndoAnchor implant fixation in EVAR.

Primary AAA arm (n = 771)

ANCHOR Registry real-world outcomes

Learn about the ANCHOR Registry design methods, results, and proven durability of ESAR with the Heli-FX EndoAnchor system in challenging AAA patients.

Baseline patient characteristics

Infrarenal neck diameter: 23.9 mm (mean)
Infrarenal angulation: 36.6° (mean)
Aneurysm diameter: 59.3 mm (mean)
Neck length: 15.0 mm (median)
Conical neck (> 10%/10 mm): 42.5% (276/649)

Aortic illustration of the Heli-FX patient baseline characteristic diagram

Stent graft used (N = 750)

Endurant™ II/IIs stent graft system: 61.5%
Excluder™* AAA endoprosthesis: 26%
Zenith™* AAA endovascular graft: 9.9%
Other: 2.6%

Pie chart illustrating the stents grafts used in the primary arm from the ANCHOR registry

Columns


Female	21.3%
Average age	73.5 years
Hostile necks	88.7% (572/645)
ASA Class III/IV	87.8% (674/768)
Urgent or emergent	17.9% (119/664)

Perioperative outcomes

Columns


Technical success	98.8% (738/747)
Average time to place EndoAnchor implants	19.6 min
Average number of EndoAnchor implants	6.0
Average total procedural time	143.7 min
Average total fluoro time	35.1 min

Outcomes

Columns

ANCHOR primary AAA arm (N = 771)	Year 1	Year 2	Year 3	Year 4	Year 5
Type Ia endoleak	2.5% (14/568)	1.7% (6/346)	2.9% (7/238)	3.2% (5/154)	4.8% (4/84)
Migration	0.0% (0/368)	0.0% (0/180)	0.0% (0/114)	0.0% (0/72)	0.0% (0/37)

ESAR promotes sac regression

Strong five-year sac regression in hostile necks

62.5% (50/80) sac regressing
88.8% (71/80) of stable or regressing

Long-term clinical durability (N = 771)

ANCHOR five-year results demonstrate durable, reinforced proximal seal

>89.0% FF type Ia endoleak
96.0% FF reinterventions for type Ia
97.7% FF rupture
98.4% FF aneurysm-related mortality (ARM)