Medtronic (NYSE:MDT) said today it launched a study of its Endurant II and IIs stent graft systems, designed to treat abdominal aortic aneurysms, exploring the use of the device in ChEVAR procedures in real-world settings.
The 150-patient, single-arm study is slated to enroll patients at 25 sites across Europe and Russia, with the first enrollments already underway at Munster, Germany’s St. Franziskus Hospital led by principal investigator Dr. Giovanni Torsello.
“We are excited to initiate this study in a real-world population, which will build upon existing clinical evidence for the ChEVAR technique as a standardized approach for treating short infrarenal necks. We believe the study marks another significant milestone for patients with complex forms of aortic disease who, until recently, had not been suitable for a minimally-invasive endovascular procedure,” Dr. Torsello said in a prepared statement.
The ChEVAR procedure includes a parallel graft chimney technique using covered renal stents and a standard aortic stent graft.
Fridley, Minn.-based Medtronic said the study will be the first to assess clinical outcomes, safety and performance when using the ChEVAR technique for patients with complex aneurysms with short infrarenal neck lengths of less than or equal to 2 mm in real-world settings.
“As the only stent graft company with a ChEVAR indication, we are deeply invested in delivering solutions, in partnership with the clinical community, that are backed by clinical rigor and address the unmet needs of AAA patients. This is the first industry-sponsored study to evaluate the ChEVAR technique in this patient population, and is another testament of our ongoing commitment to innovation in complex aortic disease and superior clinical outcomes,” aortic biz VP & GM Daveen Chopra said in a press release.
Last month, Medtronic said it won CE Mark approval in the European Union for combined treatment with its Endurant II or IIs stent graft and the Heli-FX EndoAnchor system in patients with short aortic anatomies.