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 is indicated for patients with aortic neck lengths <10mm and ≥4mm and <60° infrarenal angle.
Medtronic offers the first EVAR with EndoAnchor fixation for patients with AAA necks <10mm and ≥4mm.
CLINICAL OUTCOMES
ANCHOR Registry short neck one year clinical results support the use of Endurant II/IIs system and Heli-FX EndoAnchor system in short aortic necks.*
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
- 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:
A Infrarenal Diameter: 25.7 mm
B Neck Calcium Thickness: 1.31 mm
C Infrarenal Angulation: 20.6°
D Neck Length: 6.86 mm†† (4.06-9.97 mm)
E Neck Thrombus Thickness: 0.85 mm
F Aneurysm Diameter: 57.7 mm
SUCCESSFUL INITIAL IMPLANT PROCEDURES
| 97.1% (68/70) |
Overall investigator-reported procedural success|| |
|---|---|
| 92.9% (65/70) |
Successful and accurate deployment of EndoAnchor™ implants‡ |
| 88.6% (62/70) |
Technical success# |
Positive 1-YEAR
OUTCOMES
| 1.9% (1/53) |
Type Ia Endoleak |
|---|---|
| 1.6% (1/64) |
Type Ia-related Secondary Endovascular Procedures |
| 4.9% (3/64) |
Overall Secondary Endovascular Procedures |
| 0% (0/64) |
Conversion to Open Surgical Repair |
| 0% (0/64) |
Rupture |
HELI-FX™ ENDOANCHOR™ IMPLANTS USED WITH ENDURANT™ STENT GRAFT promote positive AAA sac dynamics**
AAA Sac Diameter Changes – Core Lab at 12 Months, N=54
*
AAA Neck length ≥4 and < 10 mm
†
Data on file. As of June 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.
||
Two investigator-reported cases of unsuccessful procedures: 1) failure to deliver the main body endograft to intended landing zone, 2) persistent Type Ia endoleak
¶
There were 4 cases where the investigator assessed that one EndoAnchor™ implant did not penetrated the aortic wall and 1 case of unsuccessful implantation of EndoAnchor™ implants.
#
At least 1 EndoAnchor™ implant didn’t adequately penetrate aortic wall (N=4, All 4 procedures determined to be successful by the investigator). Unsuccessful delivery of main body to intended landing zone (N=3, Endografts delivered slightly distal to intended target; 1 cuff covered renal). One subject with combination of low endograft landing, unintentional coverage of a renal artery with cuff, and unsuccessful implant of EndoAnchor™ implants).
**
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.
††
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).
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.
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