In Critical Limb Ischemia (CLI), fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene. Patients with CLI are at an immediate risk for limb amputation and death. It is estimated that 5-6 million people in U.S. and Europe suffer from CLI and this number is projected to grow with an estimated cost of 25 billion $ per year in the U.S. alone. With the increasing rate of diabetes, this number is projected to grow in the coming years.
While some non-surgical treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need revascularization with vascular bypass surgery or an endovascular procedure to try to prevent a major limb amputation and prolong survival. However, up to 40% of patients are unsuitable for revascularization and experience up to a 40% amputation rate at 1 year.
In view of the lack of suitable therapeutic options for the growing population of CLI patients, new approaches are warranted in order to reduce the number of amputations and their impact on quality of life and on life expectancy.