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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 patients with aortic neck lengths less than 10 mm and down to 4 mm.* For successful EndoAnchor implantation, neck must be free from significant thrombus, calcification, or plaque.
Medtronic offers the first ESAR with EndoAnchor fixation for patients with short aortic necks.†
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†
(N = 70) — core lab mean measurements
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)
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.
Type Ia Endoleak¶
Type Ia-related Secondary Endovascular Procedures#
|Conversion to Open Surgical Repair|
Heli-FX EndoAnchor Implants Used with Endurant Stent Graft Promote AAA Sac Regression**
AAA Sac Diameter Changes — Core Lab
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.
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