Medical device firm LimFlow has secured CE mark approval for its percutaneous critical limb ischemia (CLI) technology.
The LimFlow system has been developed for venous arterialization of the lower limbs in end-stage patients at risk of limb amputation for CLI, which is the severe form of peripheral artery disease (PAD).
According to the company, the system is a novel percutaneous therapy for patients who have exhausted all current revascularization options. It can be used to enhance chronic wound healing and avoid major amputation.
The system uses advanced ultrasound guided catheters and covered nitinol stents to bypass diseased arteries and divert blood flow into the tibial vein in order to vascularize the entire ischemic foot.
The company completed first-in-man and CE mark studies for the LimFlow system.
LimFlow CEO Dan Rose said: “Utilizing the existing alternative pathway of the venous vasculature, the LimFlow System is designed to reestablish perfusion for patients that have chronic, non-healing wounds and are in imminent danger of losing a limb.
“We can now provide an option for patients that have none today. In early clinical cases, we have seen patients with extensive and severe foot wounds, including gangrene, fully heal following treatment with the LimFlow therapy, becoming mobile and active again.”
LimFlow is engaged in the development of treatment for critical limb ischemia, a prevalence of diabetes, heart disease and an aging population.