Medtronic's Endurant II Stent Graft Wins Expanded CE Mark Indication

Medtronic announces its Endurant II/IIs Stent Graft System has earned CE Mark for an expanded indication. The regulatory win gives abdominal aortic aneurysm patients with short aortic necks an "off-the-shelf" option for endovascular aneurysm repair.

Patients who have abdominal aortic aneurysms (AAA) with complex anatomies can now undergo endovascular aneurysm repair with a ready-made device option. Medtronic's Endurant II/IIs stent graft system, used in endovascular aneurysm repair (EVAR), has been granted CE Mark for an expanded indication in patients with aortic necks as short as 2 mm, the company announced in a news release.

The indication includes use of the system during a chimney EVAR (ChEVAR) procedure. During a ChEVAR procedure, clinicians use balloon-expandable, covered chimney stents to stent the renal arteries. Then, an abdominal aortic stent graft system, such as the Endurant II/IIs, can be used to address the AAA.

Medtronic's device previously had CE Mark for use in patients with aortic necks 10 mm or longer.

The aortic neck is the portion of the patient's aorta above the aneurysm and below the renal arteries. Aortic neck length is an important feature in endovascular aneurysm repair, as most stent grafts are anchored in the aortic neck--sometimes called "the landing zone." With very short aortic necks, there is often not enough room to anchor the endovascular device without blocking the renal arteries.

This CE Mark expansion gives Medtronic the first ChEVAR indication.

"Treating aneurysm patients with short aortic necks has been a long-time challenge for clinicians performing endovascular aneurysm repair (EVAR) to treat AAA patients," Giovanni Torsello, MD, chief of vascular surgery at St. Franzkisus Hospital in Munster, Germany, said in the company's release. "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."

Torsello was a coauthor of the PeRfOrmance of The EndurAnt abdominal stent-Graft in the treatment Of paraRenal pAthologieS by the chimney technique (PROTAGORAS) study. This study evaluated the Endurant stent graft in patients with complex aortic anatomies using the ChEVAR procedure. The study results were published in the Journal of Vascular Surgery. According to the journal article, the ChEVAR procedure was used to successfully implant 128 patients with the Endurant graft. The mean aneurysm sac regression was 60.8 mm (p=0.001) out to a mean follow-up of 24.6 months. Primary chimney graft patency was 95.7%. Two patients (1.6%) had late new onset of a Type IA endoleak. Mortality at 30 days was 0.8% while midterm mortality was 17.2%.

Medtronic's Endurant II/IIs has not yet received FDA approval for an expanded indication. In the United States, the system can be used in AAA patients with aortic neck lengths >10 mm with up to 60 degrees of infrarenal angulation (the angle of the aorta below the renal arteries).

"The expanded indication for our Endurant II/IIs stent graft system is a great example of how we can deliver solutions to address unmet clinical needs and improve standard of care for patients who have aneurysms with short neck lengths," Daveen Chopra, vice president and general manager of Medtronic's Aortic business, said in the release. "We are excited to expand our leadership in EVAR with the first aortic stent graft approved for use with the ChEVAR technique." 

[Image courtesy of MEDTRONIC]