Medtronic's Endurant Stent Graft Demonstrates 96.2% Freedom from Aneurysm Rupture at 10 Years in Real-World ENGAGE Registry

Medtronic in "European Journal of Vascular and Endovascular Surgery (EJVES)》Published onEndurantTen-Year Research Data on Endovascular Stent Graft Treatment for Abdominal Aortic Aneurysm (AAA).

This studyEndurant After obtaining CE approval in 2008, the study was initiated, enrolling a total of 1,263 patients from 49 centers across 21 countries. This publication reveals the ten-year follow-up data of approximately 390 patients, showing that:

• Long-term efficacy(10 years):

All-cause mortality exempt from research center reports: 97.3%

Aneurysm-related mortality as adjudicated by the Clinical Events Committee: 75.7%

Freedom from Open Surgical Revision Rate: 99.4%

Freedom from Aneurysm Rupture Rate: 96.2%

Freedom from Aneurysm-Related Reintervention Rate: 71.4%

• Comparison data for the previous five years:

Freedom from Aneurysm Rupture Rate: 99.2%

Freedom from Aneurysm-Related Reintervention Rate: 83.6%

• Late Reintervention (72 cases): Type Ia Endoleak (18 cases), Type II Endoleak (18 cases), Type Ib Endoleak (16 cases)

• Tumor Cyst Changes (at 10 years): Reduced (64.1%), Stable (19.2%), Enlarged (16.8%)

Research Conclusion

In the ENGAGE registry study, among the patient population surviving beyond 5 years, it was observedEndurantWith sustained effectiveness and durability.

Study Limitations

Due to some patients/centers not agreeing to the protocol amendment, the extended follow-up cohort data cannot fully represent the original cohort. However, providing baseline difference explanations allows readers to assess potential biases; the lack of a control group means results can only be indirectly compared with other studies; the COVID-19 pandemic led to decreased compliance with the 5-10 year follow-up.

Endurant II/IIsIt is a stent graft applicable for the treatment of infrarenal or juxtarenal abdominal aortic or aortoiliac aneurysms. It has been approved for marketing by regulatory authorities such as the FDA, CE, and NMPA.

• Flexibility and Adaptability

Designed to conform to the natural curvature of blood vessels.UltraThe thin hydrophilic delivery coating enhances accessibility and traceability.

• Accurate Placement and Controlled Deployment

Flexible, Anti-Kink Delivery SystemFacilitates stent delivery. Tip capture is used for precise positioning adjustments, including adjustments to the proximal or distal positions.

• Optimal Sealing and Fixation

M-type proximal stent provides superior apposition performance and reduces folding. Renal stent offers safer fixation.

• Durability and Strength

High-density, multi-filament polyester graft material provides low porosity to resist aneurysm sac growth.

• Extended Anatomical Customization Options

• Provide a shorter ipsilateral leg for more flexible and targeted limb placement.

• With equal leg diameters, allowing the legs to be used on either side.

• Compared with Endurant II, the distal diameter can be reduced by 20%.

• Supports selecting the in-situ size of the ipsilateral limb, allowing 3-5 stents to overlap for adjustments during the procedure.
• Enables easier pre-case planning to streamline surgery.