Device for creating branched stent graft * Insitex

Device for fenestration of stent graft on location – Insitex
Prof. Yehuda Wolf, Head of vascular Surgery Department, Tel Aviv
Medical Center
Aortic aneurysms are local dilatations of the aorta (the main artery of the body
running from the heart to the pelvis) that are prone to rupture and cause fatal bleeding.
The most common variety is in the abdomen - abdominal aortic aneurysm (AAA).
Aortic aneurysms are increasingly treated by the endovascular method, employing
stent grafts inserted from the groin, rather than by open surgical repair. The global
market for endovascular AAA repair was valued at $820 million in 2008 and is
expected to reach $1.6 billion by 2015 and the global market for thoracic aortic stent
grafts and access devices was estimated at $70 million in 2006 and is expected to
reach 259 million, globally, by 2012. Over 10 companies are in fierce competition
over this field.
The most important limitation to universal application of endovascular aortic
aneurysm repair is the presence of vital branches in the aneurysm or in close
proximity to it, which can be treated with open surgery but requires special
technology for endovascular repair. At this time, the only endovascular solution is the
use of custom-made fenestrated (with side-holes) stent grafts which are produced by
one company only, take 6-8 weeks to produce, are extremely expensive, very difficult
to place and are suitable for a subgroup of anatomically suitable patients.
The object of invention is the Insitex device which is a temporary, removable spacer
(stent-like scaffold) which can be inserted into the aorta before deployment of the
aortic stent graft to allow creation of a fenestration on location (in situ fenestration)
without the need for custom-made or prefabricated fenestrated grafts. This approach is
very versatile and can be applied to almost any anatomy in the abdomen and thorax. It
can be used to create the fenestration from the aorta outwards, and in the thorax, also
from the branch artery inwards.
This device may enable application of endovascular repair and enlarge the market of
endovascular stent grafts to a large proportion of aneurysm patients for whom
currently the only available option is open surgical repair.