Abdominal Aortic Aneurysm (AAA) is a common disease in Western countries; the prevalence of AAA is 2–5% in men over 65 years old, and 1–2% in women over 65 years old. 1–2% of all deaths in the Western world are estimated to be caused by AAA ruptures. The overall patient mortality rate for ruptured AAA is approximately 80%, in the USA, and between 85% and 95% in Europe, making it among the leading causes of death globally.

Minimally-invasive Endo-Vascular Aortic repair (EVAR) has steadily become the standard of care in the management of AAA; it has now surpassed open surgical repair and is the predominant therapeutic modality in managing this disease entity. Today, despite great advances in product development, about 40% of overall patients do not qualify for conventional EVAR due to challenging anatomies; current treatment options for these patients are extremely limited. Within this sub-group of patients, females and the Asian population have an even higher percentage of unqualified patients for EVAR. Women are considered outside the acceptance criteria for EVAR 5.5 times more often than men due to aneurysms and reasons related to vessel morphology.

Current endovascular solutions for complex AAA using chEVAR (“Chimney” techniques) and FEVAR (Fenestrated Endo-Vascular Aortic repair) products do not provide an adequate solution. "Chimney" techniques are associated with a high percentage of postoperative complications, a huge risk for stroke and significantly high rates of endoleak (Type Ia), chEVAR failure leads to open surgery conversion, an unacceptable risk for the high-risk patients.  While FEVAR is safer than chEVAR, and has a lower number of postoperative complications, it still has a high (29%) postoperative acute renal failure (ARF) events and high reintervention rate based on the intermediate and long-term clinical results.  FEVAR in its current form is a customized solution designed to fit individual patients' anatomies and is suitable for only for 20% of women.

BifSol’s vision is to simplify complex endovascular procedures, thereby opening up this less invasive and effective treatment option to a wider audience of physicians and patients. The BifSol innovative platform will enable minimally-invasive endovascular procedures that are currently considered infeasible. Our product, the BifSol Suprarenal Stent-Graft, is a complimentary “add-on” device to be incorporated into off-the-shelf traditional EVAR endograft solutions in order to facilitate repair of complex anatomies. The mounting of the add-on product onto the endograft will enable treatment of aneurysms that cannot be treated today with conventional EVAR devices.