First experience with the new repositionable C3 excluder stent-graft

Area of Science:

• Vascular Surgery
• Medical Device Technology
• Aortic Aneurysm Treatment

Background:

• The Gore Excluder device is a third-generation endovascular aneurysm repair (EVAR) device.
• Previous iterations faced challenges with precise proximal deployment accuracy and control.
• A novel deployment system was engineered to address these limitations.

Purpose of the Study:

• To evaluate the efficacy and safety of a new deployment system for the Gore Excluder device.
• To assess the system's ability to allow graft repositioning for optimal level and orientation.
• To improve proximal fixation and sealing in EVAR procedures.

Main Methods:

• The new deployment system was utilized in a cohort of 25 patients undergoing EVAR for infrarenal abdominal aortic aneurysms.
• The system's functionality for graft repositioning and contralateral limb catheterization was assessed.
• Clinical outcomes and procedural success rates were documented.

Main Results:

• The system facilitated graft repositioning in 72% of cases, primarily for improved proximal positioning or contralateral limb access.
• Graft repositioning for orientation was the most frequent application of the new system.
• All treated grafts were successfully repositioned to the desired final location without the need for additional cuffs.
• No Type I endoleaks were observed on completion angiography or initial computed tomography scans.
• Zero surgical mortality was recorded, with all patients discharged in stable condition.

Conclusions:

• The new deployment system effectively enables precise repositioning of the Excluder graft, ensuring optimal fixation and sealing.
• This system enhances the control and accuracy of EVAR procedures.
• A global registry is established to monitor long-term, real-world performance of the device.