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Stent graft system approved for treatment of AAA with hostile neck anatomy
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Medtronic announced that its stent graft for the treatment of abdominal aortic aneurysm in patients with short, hostile aortic neck anatomies has been approved by the FDA.
According to a press release from the company, the stent graft (Endurant II/III) is designed to treat patients with neck lengths down to 4 mm and 60 degree or less infra-renal angulation when combined with Medtronic’s Heli-FX EndoAnchor system.
Certain patients with short infra-renal necks were previously ineligible for endovascular aneurysm repair, according to the release.
“Previously, these patients needed to have more complex endovascular techniques including fenestrated endografts or parallel endografts, also known as snorkel grafts, that required cannulation of the renal arteries for more proximal fixation,” William Jordan, Jr., MD, professor of surgery and chief of the division of vascular surgery and endovascular therapy at Emory University School of Medicine, told Cardiology Today’s Intervention. “This technique can be used in the infra-renal position without placing renal stents/grafts and can simplify some treatments for complex patients.”
The basis of the FDA approval was the global multicenter, prospective post-market ANCHOR Registry, in which the system conferred in patients with neck lengths 4 mm to < 10 mm a technical success rate of 88.6%, a procedural success rate of 97.1%, a 1.9% rate of proximal type Ia endoleaks at 1 year and no abdominal aortic aneurysm expansions, migrations or ruptures at 1 year, the company stated in the release.
“A broader indication gives us more confidence that these patients can be treated with a standard infrarenal endograft adding the supplement of endoanchors to provide the stability and strength of a surgical anastomosis. These patients with short necks and difficult anatomy can be assessed with the idea of using endoanchors,” Jordan told Cardiology Today’s Intervention. “One should gain some experience with using this relatively new tool because it also takes precision to gain an accurate placement just below the renal arteries and secure a stable repair.” – by Dave Quaile
Disclosure: Jordan reports no relevant financial disclosures.