LimFlow System for treatment of critical limb ischaemia receives CE Mark- LimFlow S.A.

LimFlow SA, developer of endovascular technology transforming the treatment of critical limb ischemia (CLI),announced that it received the CE Mark (Conformit� Europ�enne) for its fully percutaneous LimFlow System designed for venous arterialization of the lower limbs in end-stage patients at risk of limb amputation for CLI.

Critical Limb Ischaemia is the most severe form of peripheral artery disease (PAD) and often occurs in patients suffering from coronary artery disease, diabetes, obesity, high cholesterol and high blood pressure, many of which are growing health problems. Patients with CLI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life. To relieve the symptoms of CLI, appropriate patients are treated with Percutaneous Transluminal Angioplasty (PTA) or with open and complex Distal Bypass Surgery (DBS). In many late-stage patients, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

The LimFlow System is a novel percutaneous therapy for patients who have exhausted all current revascularization options. It is designed to promote chronic wound healing and avoid major amputation. It uses proprietary ultrasound guided catheters and covered nitinol stents to uniquely bypass diseased arteries and divert blood flow into the tibial vein in order to vascularize the entire ischemic foot.