Medtronic has initiated the European market launch of its Endurant abdominal stent graft system as well as a U.S. clinical trial with the first Endurant implants.
The Endurant stent graft was granted the CE Mark last week, and Medtronic said will begin commercialization in mid-July. Outside the United States, the Endurant system expands the applicability of endovascular aortic repair (EVAR) to patients with abdominal aortic aneurysms, according to the Minneapolis-based company.
The Endurant stent graft system is an investigational device in the United States, where it is limited to investigational use only.
The first implants of Endurant in the U.S. clinical trial took place during the last two weeks, with excellent periprocedural results, Medtronic reported. The initial implants at the Cleveland Clinic were performed by Matthew Eagleton, MD, Timur Sarac, MD, and Vikram Kashyap, MD; those at Scott & White Memorial Hospital in Temple, Texas, were completed by a team led by C. J. Buckley, MD.
Approved by the FDA in June under an investigational device exemption, the U.S. clinical trial of Endurant is designed to evaluate the device’s safety and effectiveness in the endovascular treatment of abdominal aortic aneurysms, according to Medtronic.
The pivotal trial for Endurant will be used to seek FDA approval of the device. Medtronic said that the study will enroll 150 patients at up to 30 U.S. sites in the next 12 to18 months.
All patients who meet the single-arm study’s inclusion criteria will receive an Endurant; their outcomes will be compared to outcomes from a pivotal study of the Talent abdominal stent graft, which led to that device’s FDA approval, according to the company.