Medtronic has announced that the first two European patient cases with the Endurant Evo AAA stent graft system were successfully performed by Hence Verhagen, chief of vascular surgery and his team at the Erasmus Medical Center in Rotterdam, the Netherlands.
Medtronic began a clinical study in April 2015 to evaluate the safety and effectiveness of the Endurant Evo AAA stent graft system, an investigational medical device designed to expand the applicability of a minimally invasive alternative to open surgical repair for the treatment of abdominal aortic aneurysms.
The first patient was 70 years old and had a 52mm aneurysm. The implant was placed with a percutaneous approach enabled by the device’s low profile. The case was successful, with no endoleaks at the final control. The second patient was 74 years old and had a 55mm aneurysm. All the devices were correctly positioned thanks to the 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.
“The Endurant Evo AAA stent graft system has the potential to improve the treatment for abdominal aortic aneurysms. The system is well designed and the simplified procedure helped to reduce the procedure time,” said Verhagen.
The study will enroll 140 patients with infrarenal abdominal aortic or aortoiliac aneurysms at up to 30 sites in Europe and the USA. All study patients will be treated with the Endurant Evo AAA stent graft system. The study will evaluate safety and efficacy of the new stent graft system. The 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. Safety endpoint is defined as the proportion of subjects free from a major adverse event within 30 days post-implantation.
Clinical evidence from the study will be used to seek regulatory approvals required to commercialise the Endurant Evo AAA stent graft system in Europe, USA and other markets around the world.
“Medtronic is committed to improving the detection and treatment of aortic disease globally,” said Daveen Chopra, vice president and general manager of the Aortic franchise at Medtronic. “The Endurant Evo AAA stent graft system provides another proof point for our enduring commitment to invest in innovation for the endovascular treatment of complex aortic disease.”