The Endovascular Stapler (EVAS) is designed to fixate stent-grafts in place potentially preventing migration and possibly endoleakage. This may reduce the need for patients to undergo second, corrective procedures following stent- graft failure. EVAS can be used with practically all types of existing stent-grafts allowing current stent grafts to become the first choice surgical option for AAA patients.
Approx. 45,000 AAA stent-grafts implanted in the US & EU at a cost of $10-25K each
Current AAA stent-grafts suffer from endoleaks and migration problems limiting their wide adoption
Efforts to overcome these problems by better attachment mechanisms produced inadequate results
ES Vascular's staplers of different diameters are inserted as an adjunct to current stent graft procedures. Once the stapler is in place the staples are deployed in one shot, firmly fixating the stent graft to the aortic wall and possibly preventing one of the most common problems of current EVAR devices.
An adjunct to current products - anticipated simple 510K regulatory route
Characteristics
External diameter when inserted through the femoral access point is 8mm
Fully extended diameter after positioning and before final fixation is up to 34mm
Number of staples fired in one shot is 3 (up to 5)
Stapler images (click to enlarge)
Procedure
Standard EVAR is perfomed
Via the same femoral access, an EVAS is inserted
When the EVAS tip is visualized and positioned the staples are fired
The EVAS is retracted and removed
EVAR Endostapler Project Status
90% of developmental work is completed
Minimal risk - technology is developed
First clinical study to be implemented in early 2008
EVAR Endostapler Project Status
8 patent families have been filed. One US patent has been granted, the rest are pending.
Approx. 45,000 AAA stent-grafts implanted in the US & EU at a cost of $10-25K each
Characteristics
