A novel fully non-occlusive stent-graft moulding balloon-catheter

Problem:

Molding balloons are used to prevent and treat type 1(at the proximal or distal end) and type 3 (between two stent-grafts) endoleaks during aortic stent-graft placement. A device that does not require any action to lower cardiac output during the moulding procedure would be highly desirable as it would make the procedure safer and quicker.

Product:

A fully non-occlusive Balloon-catheter was developed that does not restrict blood flow and allows for a safe moulding procedure without the risk of displacement of the stent-graft. The balloon-catheter consists of two high pressure nylon balloons mounted inside a nitinol frame in a zig-zag configuration. Upon inflation the zig-zag will straighten thereby expanding the nitinol frame and align the stent-graft to the aortic wall. It is available in two sizes of 26-46 mm or 20-36 mm. The larger device is compatible with an 18 Fr and the smaller with a 12 Fr introducer sheath.

Medical Significance:

As the balloon is completely non-occlusive there is no risk of displacement and also permanent blood flow to the lower body. Therefor the balloon cannot only be inflated while the heart is ejecting normally without any risk but also the moulding procedure can be extended which should allow for a better alignment of the stent-graft to the aortic wall.

Target Markets:

All patients that undergo a thoracic or abdominal aortic stent-graft implantation. In acute pathologies in the thoracic aorta moulding of the stent-graft is usually not done this would be approximately half of all patients undergoing a thoracic stent-graft implantation and nearly all patients undergoing an abdominal stent-graft implantation.

Team:

This device was developed by a team of engineers of Strait Access Technologies, a South African start-up company and three European cardiac surgeons that are implanting stent-grafts and thereby have profound knowledge of endovascular aortic therapies.