First European Patients Enrolled in Study of Medtronic's Endurant Evo AAA Stent Graft System

August 7, 2015—Medtronic plc announced that the first two European cases in the clinical study of its Endurant Evo abdominal aortic aneurysm (AAA) stent graft system were successfully performed by European Principal Investigator Prof. Hence Verhagen, MD, Chief of Vascular Surgery, and his team at the Erasmus Medical Center in Rotterdam, the Netherlands. In Medtronic’s press release, Prof. Verhagen stated, “The Endurant Evo AAA stent graft system has the potential to improve the treatment for AAAs. The system is well designed, and the simplified procedure helped to reduce the procedure time."

In an interview with Endovascular Today, Prof. Verhagen commented, “The Endurant Evo device is so small that it is particularly suitable for percutaneous access. All our cases so far have been strictly percutaneous with great results. We have seen a few patients for their 1-month follow-up visits, all with perfect anatomical results and without any suspicion of endoleaks.” He added, “It is important to note that the Endurant Evo trial is a designed to support both CE Mark and US Food and Drug Administration approvals, which is the first time this has been done.”

According to the company, the first patient was 70 years of age and had a 52-mm aneurysm. The case was successful, with no endoleaks at the final control, and was performed with a percutaneous approach enable by the device’s low profile. The second patient was 74 years of age and had a 55-mm aneurysm. All the devices were correctly positioned with the device’s three-piece approach and in-situ sizing capabilities after a planned coiling and overstenting of one hypogastric artery. The precise deployment resulted in procedural success with no endoleaks at the final imaging.

In April 2015, Medtronic announced the beginning of the clinical study to evaluate the safety and effectiveness of the Endurant Evo AAA stent graft system, which is an investigational device designed to expand the applicability of endovascular aneurysm repair as an alternative to open surgical repair for the treatment of AAA. The study will enroll 140 patients with infrarenal abdominal aortic or aortoiliac aneurysms at up to 30 sites in Europe and the United States. All study patients will be treated with the Endurant Evo AAA stent graft system.

The study’s primary effectiveness objective is to evaluate successful delivery and deployment of the Endurant Evo AAA stent graft system with successful removal of the delivery system during the index procedure. The safety endpoint is defined as the proportion of patients free from a major adverse event within 30 days after implantation.

Clinical evidence from the study will be used to seek regulatory approvals required to commercialize the Endurant Evo AAA stent graft system in Europe, the United States, and other markets around the world. The Endurant Evo AAA stent graft system is available only as an investigational device for use in the current clinical study, which has been approved by European regulatory bodies and the US Food and Drug Administration.

Medtronic stated that the Endurant Evo AAA stent graft system, based on the company’s Endurant platform, features an evolved design that aims to simplify the implant procedure and increase patient customization options. The three-piece system and adjustable limb length simplifies case planning and reduces inventory. The system’s 3-F reduction in profile down to 15 F (outer diameter) facilitates vascular access, and its multiple aortic body lengths and a larger range of limb lengths and diameters improve patient customization. The Endurant Evo AAA stent graft system also features an enhanced delivery system that eliminates the tip-recapture step and incorporates an integrated flush port for contrast injection, advised the company.