LimFlow has developed a revolutionary way of treating patients at risk of amputation.
Critical Limb Ischemia (CLI) is a complication of Peripheral Vascular Disease, a very frequent consequence of diabetes. It is characterized by profound, chronic pain, as well as extensive tissue loss that restricts revascularization options and frequently leads to amputation. CLI is estimated to have a fast growing incidence of approximately 50 to 100 per 100,000 per year, and is associated with mortality rates as high as 20% at 6 months after onset. Once ulcers appear on the patient's feet, it is very difficult to reverse the condition, and there is no alternative but amputation in a relatively short time frame.
The novel LimFlow approach to treating CLI employs the concept of venous arterialization (creating a shunt between an artery and a vein to restore blood flow to the foot through a vein, despite a clogged artery). Venous arterialization has been performed surgically for many years, with the first clinical surgical cases reported in the early twentieth century. However, it is deeply invasive and has not been widely adopted.
LimFlow has received CE mark in 2016, and is currently recruiting patients in its FDA pivotal trial.