Market

abdominal aortic aneurysm

Background

Abdominal aortic aneurysms (AAA) occur in the part of the aorta that passes through the abdomen (abdominal aorta). The abdominal aorta represents the location of 80% of all aortic aneurysms.


Approximately 4.5 million people in the developed world are living with an AAA. As many as 8% of people over the age of 65 have an AAA*.


While smaller aneurysms rarely rupture, those that get wider (5 centimeters and over) often require surgery due to the increased chance of rupture. Aortic aneurysms are most often treated with a conventional endovascular aneurysm repair (EVAR) using commercially available stent-grafts, versus open surgical repair, an invasive, complicated, and lengthy (4 to 6 hour) procedure. Approximately 50% of patients who do not undergo treatment die of ruptured AAAs*. Ruptured AAAs represent the tenth leading cause of death in men over 55, accounting for more than 15,000 deaths in the United States each year. However, approximately 40% of patients are not suitable candidates for EVAR due to inadequate aortic neck anatomy (<12 mm)*.


Currently, there are very limited, expensive procedures for those prevented from undergoing EVAR. Many patients who do not qualify for EVAR will benefit from BiFlow Medical’s side-branch stent and will then be candidates for EVAR.

Technical improvements in graft design and advances in delivery techniques will result in the increased application of EVAR.