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HOSTILE NECK ENDOSUTURE ANEURYSM REPAIR Endurant II Stent Graft Systems

Watch the story of how an aortic patient with complex anatomy was treated with Endurant system + ESAR.
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Overview

The Endurant™ II/IIs AAA stent graft system used in combination with the Heli-FX™ EndoAnchor™ system is the first AAA short neck solution independent of renal stenting. Where approved for this use, Endurant II/IIs with Heli-FX EndoAnchor system is indicated for hostile aortic neck treatment*. For Successful EndoAnchor implantation, neck must be free from significant thrombus, calcification, or plaque.

Illustration of a short neck EndoSuture aneurysm repair using the Endurant II/IIs stent graft with Heli-FX EndoAnchor system

Medtronic offers the first ESAR with EndoAnchor fixation for patients with short aortic necks.†

CLINICAL OUTCOMES

ANCHOR short neck one-year and two-year clinical results support the use of Endurant II/IIs system + Heli-FX EndoAnchor system in short aortic necks†

  • 70 patients enrolled
  • 93% ASA class III/IV
  • 6.9 mm mean proximal neck length, (4.06–9.97 mm)

ANCHOR REGISTRY SHORT NECK COHORT

  • Design: Post-market, prospective, multi-arm registry with core lab analysis
  • Enrollment: 70 subjects in the short neck cohort were analyzed at 19 U.S. and 3 EU sites‡
  • Eligibility: Proximal neck length ≥ 4 mm and < 10 mm, as measured by the core lab
    • The neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter.
  • Primary Outcomes:
    • Type Ia endoleak rate at 1 month (core laboratory assessed)
    • Type Ia endoleak rate at 12 months (core laboratory assessed)
    • Re-intervention rate through 12 months§
    • Technical success rate||
  • Secondary Outcomes: Index procedure outcomes, device-related events, safety- and effectiveness-related measures

Baseline Anatomical Characteristics

(N = 70) — core lab mean measurements

Mean measurements:

  1. Infrarenal diameter: 25.7 mm
  2. Neck calcium thickness: 1.31 mm
  3. Infrarenal angulation: 20.6°
  4. Neck length: 6.86 mm
  5. Neck thrombus thickness:
    0.85 mm
  6. Aneurysm diameter: 57.7 mm
Illustration of aortic aneurysm with callouts to the baseline characteristics of core lab anatomical mean measurements
Icon depicting average number of 148 minutes procedure duration of the ANCHOR Registry short neck cohort

148 min: Procedure Duration

Icon depicting average number of 17 minutes time for EndoAnchor implant duration of procedure of the ANCHOR Registry short neck cohort

17 min: Time for EndoAnchor Implant

Icon depicting average number of 35 minutes fluoro time in procedure of the ANCHOR Registry short neck cohort

35 min: Fluoro Time

Icon depicting average number of 5.5 EndoAnchor implants used in procedure of the ANCHOR Registry short neck cohort

5.5: Average Number of EndoAnchor Implants

SUCCESSFUL INITIAL IMPLANT PROCEDURES

Overall procedural success: 97.1% (68/70)

Two investigator-reported cases of unsuccessful procedures: 1) failure to deliver the main body endograft to intended landing zone, 2) persistent Type Ia endoleak.

Successful and accurate deployment of EndoAnchor implants: 92.9% (65/70)

There were 4 cases where the investigator assessed that one EndoAnchor™ implant did not penetrate the aortic wall and 1 case of unsuccessful implantation of EndoAnchor™ implants. 

Technical success: 88.6% (62/70)

FAVORABLE 1- AND 2-YEAR OUTCOMES

1-year 2-year  
2.0%
(1/49)		 0.0%
(0/32)

Type Ia Endoleak
 1.4%
(1/70)		 1.6%
(1/63)

Type Ia-related Secondary Endovascular Procedures#
 0%
(0/70)		 0%
(0/63)		 Conversion to Open Surgical Repair
0%
(0/70)		 0%
(0/63)		 AAA Rupture

IMPROVED SAC REGRESSION

Heli-FX EndoAnchor Implants Used with Endurant Stent Graft Promote AAA Sac Regression**

AAA Sac Diameter Changes — Core Lab

1-year, N = 52

  • 0% Expansion 
  • 44% Regression
  • 56% Stable
Pie chart illustrating the clinical outcomes of the ANCHOR Registry short neck AAA sac dynamics @ 1 year highlighting 0% sac expansion

2-year, N = 34

  • 0% Expansion 
  • 65% Regression
  • 35% Stable
Pie chart illustrating the clinical outcomes of the ANCHOR Registry short neck AAA sac dynamics @ 2 years highlighting 0% sac expansion

Resources 

1-year ESAR outcomes in short neck AAA published in J Vasc Surg.1

view the article

Heli-FX EVAR EndoAnchor System 

Discover Details
1

Arko FR 3rd, Stanley GA, Pearce BJ, et al. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg. Published online March 5, 2019.

*

Neck length measured as: Proximal neck length. Proximal neck length is defined as the non-aneurysmal aortic neck length measured from the lowest main renal artery to where the dilatation of the aneurysm begins (i.e., less than 10% increase from the diameter at the lowest renal artery).

†

AAA neck length ≥ 4 mm and < 10 mm.

‡

Data on file as of April 2017.

§

Re-interventions are defined as any endovascular or surgical procedure performed following the completion of the operative initial implantation procedure (thus on subsequent occasion after final closure of the last artery access site) which involves the targeted vascular segment treated by the Endurant™ stent graft system, including access sites and bypasses of the targeted vascular segment in which there is either manipulation of the implanted Endurant™ stent graft, or implantation or usage of additional devices.

||

Technical success defined as: successful delivery and deployment of the endograft and each EndoAnchor™ implant without unintentional coverage of the renal arteries.

As measured by core lab.

#

One patient received an additional graft extension and sac embolization to treat a Type Ia endoleak on day 9, which resolved.

**

AAA diameter increase is defined as > 5 mm increase in maximum diameter measured at 1 year as compared to 1 month post-implantation measurement.  AAA diameter decrease is defined as a > 5 mm decrease in maximum diameter at 1 year as compared to a 1 month post-implantation measurement.

The short neck indication is indicated for necks < 10 mm down to 4 mm.

All indications related to Endurant™ II/IIs Stent Graft System + Heli-FX™ EndoAnchor™ System Short Neck Indication are not approved globally. Please check your local regulatory approval status. Refer to the complete Instructions for Use manual of the Endurant II/IIs stent graft system  for the indication for use approved in your geography.

For complete product and risk information, visit manuals.medtronic.com. Consult instructions for use at this website. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat Reader with the browser.

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