Medtronic has announced its plans to start global marketing, pretty much everywhere except for the US, the company’s next generation endovascular AAA device, the Endurant Abdominal Stent Graft System. The device was recently given EU’s CE Mark of approval. The United States will likely be next, as the company is also announcing the first Endurant implants in a U.S. clinical trial.
The Endurant Stent Graft was CE (Conformité Européene) marked last week, and Medtronic will begin commercialization in mid-July. (CE mark is the European regulatory approval.) Outside the United States, the Endurant System expands the applicability of endovascular aortic repair (EVAR) to more patients with abdominal aortic aneurysms (AAAs), which are present in an estimated 1.2 million people and responsible for 15,000 deaths annually in the United States.
Building on more than a decade of industry-leading experience, the new device seeks to address those AAA patients whose aortas are highly angulated or whose aneurysms have short necks. Patients with these complex anatomies would previously have had no choice but watchful waiting or open surgical repair, in which the abdomen is opened and major organs temporarily moved in order to access the aorta. The Endurant Stent Graft System is an investigational device in the United States, where it is limited to investigational use only.
Prof. Hence Verhagen, chief of vascular surgery at the Erasmus Medical Center in Rotterdam, the Netherlands, led the European clinical trial of the Endurant Stent Graft System which supported the CE mark: “This next-generation device has performed exceptionally well in the treatment of abdominal aortic aneurysms. The Endurant System has the potential to expand the applicability of EVAR to more AAA patients who have been considered especially difficult to treat. I speak for my colleagues, too, by saying that physicians worldwide are eagerly awaiting the commercial release of this innovative new stent graft.”
The first implants of the Endurant Stent Graft System in the U.S. clinical trial took place during the last two weeks, with excellent periprocedural results. The initial implants at the Cleveland Clinic in Ohio were performed by Drs. Matthew Eagleton, Timur Sarac and Vikram Kashyap; those at Scott & White Memorial Hospital in Temple, Texas, were completed by a team led by Dr. C. J. Buckley.
Approved by the U.S. Food and Drug Administration in June under an investigational device exemption (IDE), the U.S. clinical trial of the Endurant Stent Graft System is designed to evaluate the device’s safety and effectiveness in the endovascular treatment of abdominal aortic aneurysms. As the pivotal trial for the Endurant Stent Graft, it will be used to seek FDA approval of the device. The study will enroll 150 patients at up to 30 U.S. sites in the next 12–18 months. All patients who meet the single-arm study’s inclusion criteria will receive an Endurant Stent Graft; their outcomes will be compared to those who received the Talent™ Abdominal Stent Graft as part of the pivotal study that led to that device’s FDA approval.