Medtronic Endurant II/IIs Receives CE Mark for ChEVAR Indication
December 6, 2016—Medtronic announced that it has received European CE Mark approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients using a chimney endovascular aortic repair (ChEVAR) procedure. ChEVAR is a parallel graft chimney technique that uses commercially available balloon-expandable covered stents combined with a standard aortic stent graft.
According to Medtronic, this expanded indication in the European Union enables the Endurant II/IIs stent graft system to be used in patients with complex aneurysms with short aortic neck lengths ≥ 2 mm, expanded from the previous neck length indication of ≥ 10 mm.
The new expanded ChEVAR indication will be initially commercialized in Europe and then in other countries that recognize the CE Mark approval. The Endurant stent graft system was granted approval by the US Food and Drug Administration in December 2010. In the United States, the Endurant II/IIs stent system is approved for neck lengths ≥ 10 mm and ≤ 60° infrarenal angulation, and it is not approved for this expanded indication, advised Medtronic.
The company advised that the CE Mark approval is supported by a comprehensive review of clinical data from literature using the Endurant II/IIs stent graft system with the ChEVAR technique. In the flagship PROTAGORAS study, outcomes were tracked with radiologic follow-up over a mean of 2 years. The study used a standardized procedural approach with the Endurant system and balloon-expandable covered stents.
PROTAGORAS demonstrated that standardized use of the Endurant II/IIs stent graft system with ChEVAR in 128 patients was associated with 100% technical success, statistically significant aneurysm sac regression (P = .001), 95.7% primary patency of the chimney grafts, and a low incidence of chimney-related reinterventions. The PROTAGORAS results were published by Konstantinos P. Donas, MD, et al in the Journal of Vascular Surgery (2016;63:1–7).
PROTAGORAS investigator Prof. Giovanni B. Torsello, MD, commented in Medtronic's press release, "Treating aneurysm patients with short aortic necks has been a long-time challenge for clinicians performing endovascular aneurysm repair to treat AAA patients.” He continued, “The availability of a standardized approach which increases anatomical applicability will help establish a new standard for patients with complex forms of AAA that may not have been suited for previous procedures." Prof. Torsello is Chief of Vascular Surgery at St. Franziskus Hospital in Mϋnster, Germany.