Presented to endovascular specialists at the
35^th Charing Cross International Symposium in London, a new analysis of
clinical data on the Endurant AAA Stent Graft System from Medtronic, Inc.
MDT demonstrates the implanted medical device's consistent and
compelling performance in treating abdominal aortic aneurysms across a range
of patient anatomies, from relatively straightforward to highly complex.
This subset analysis of the international ENGAGE registry for the Endurant AAA
Stent Graft, the market-leading device in its product category worldwide,
compared the influence of neck length on patient outcomes. Specifically, the
two-year data demonstrated similarly strong outcomes in patients with neck
lengths of 10mm to 15mm (short) and greater than 15mm (standard).
Historically, shorter neck lengths have been associated with limited
eligibility for endovascular repair and higher rates of adverse events.
"The Endurant AAA Stent Graft System continues to demonstrate durable
performance for endovascular repair of abdominal aortic aneurysms in a variety
of clinical and anatomical scenarios," said presenter Prof. Hence Verhagen,
chief of vascular surgery at the Erasmus Medical Center in Rotterdam, the
Netherlands. "This specific subset analysis of the ENGAGE Registry adds to the
already large body of clinical evidence on this remarkably versatile device,
which closes the outcomes gap between patients with short and standard neck
lengths."
The analysis included 123 patients with neck lengths of 10-15mm, 226 patients
with neck lengths of 15-20mm and 873 patients with neck lengths of greater
than 20mm. The two-year results demonstrated no statistically significant
differences across these three groups on any of the following outcomes:
o type I endoleak (0.0%, 0.0%, 0.7%)
o stent graft migration (0.0%, 0.0%, 0.0%)
o aneurysm rupture (0.0%, 0.0%, 1.1%)
o conversion to open surgery (0.0%, 0.0%, 1.1%)
o secondary procedures (4.2%, 6.3%, 6.6%)
In this context, neck length is the span of healthy aortic tissue between the
top of the aneurysm and the lowest renal artery, which cannot be safely
occluded. Neck length determines how much of a landing zone is available for
the proximal end of the stent graft. The Endurant AAA Stent Graft is approved
for use in patients with neck lengths of 10mm or greater.
The ENGAGE registry has enrolled more than 1,200 patients at more than 80
sites across six continents since the Endurant AAA Stent Graft System received
the CE (Conformité Européenne) mark in June 2008. With five-year follow-up
planned for all patients, it represents the most robust long-term study of any
stent graft ever initiated.
In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias. The company strives to offer products and
services that deliver clinical and economic value to healthcare consumers and
providers around the world.
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