Medtronic's Endurant Stent Graft Makes History as First and Only FDA-Approved Device for Ruptured Abdominal Aortic Aneurysm

Expert Evaluation

"This landmark achievement gathers real-world data from around the globe to evaluate the clinical performance of endovascular devices in treating ruptured abdominal aortic aneurysms (rAAA). This FDA approval, for the first time, provides confidence for doctors to adopt endovascular treatment options for rAAA patients. This milestone underscores the importance of ongoing medical education and clinical support for rAAA, enabling physicians to safely manage these complex and high-risk cases."

---Adam Beck University of Alabama

Executive Evaluation

"This important FDA approval underscores the innovative value, lasting reliability, and superior efficacy behind Endurant. We are proud to be the first in the industry to receive a label indication for rAAA treatment, which will strengthen our confidence and ability to support physicians in critical care."

---Simona Zannetti Vice President and General Manager of the Aortic Division, Cardiovascular Business at Medtronic

Rupture of an abdominal aortic aneurysm refers to the situation where the wall of the aneurysm becomes locally weakened due to pathological changes, and under the influence of blood pressure, the integrity of the aneurysm wall is compromised, causing blood to flow out of the aneurysm. An abdominal aortic aneurysm itself is a localized dilation of the abdominal aorta that is ≥50% of the normal arterial diameter. When the aneurysm wall cannot withstand the pressure of blood flow, rupture occurs, leading to blood flowing into the abdominal cavity or retroperitoneal space, causing severe consequences such as intense pain and hemorrhagic shock. Once it occurs,Rupture of an abdominal aortic aneurysm requiresEmergency surgical intervention, but due toRupture of abdominal aortic aneurysm is highly dangerous with limited treatment options, leading to an extremely high mortality rate.More than 80%).

MedtronicEndurantA product validated by over 10 years of clinical trials, in treatingGreat clinical achievements have been made in abdominal aortic aneurysms, and it can be said that this is a benchmark product in the field. After more than 10 years on the market,EndurantHas saved more than 500,000 lives worldwidePatients with abdominal aortic aneurysms.

Previously announced by MedtronicEndurantA decade-long real-world study has shownEndurantExcellent Clinical Outcomes:

• All-cause mortality free from research center reporting: 97.3%

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

• Freedom from open surgical repair rate: 99.4%

• Freedom from Aneurysm Rupture Rate: 96.2%

• Freedom from Aneurysm-Related Reintervention Rate: 71.4%

With the treatmentIndication for ruptured abdominal aortic aneurysm approved,EndurantWill be able to save tens of millions ofFor patients with ruptured abdominal aortic aneurysms, offering them a chance to survive.

Endurant II/IIsIt is a stent graft used for treating infrarenal or juxtarenal abdominal aortic aneurysms 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 lower 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 dimensions of the ipsilateral limb, allowing 3-5 stents to overlap for adjustments during the procedure.
• Enables easier pre-case planning to streamline surgery.