LimFlow System for Percutaneous Treatment of End-Stage CLI Receives CE Mark

November 15, 2016—LimFlow SA announced today it has received CE Mark approval for its fully percutaneous LimFlow System designed for venous arterialization of the lower limbs in end-stage patients at risk for limb amputation for critical limb ischemia (CLI).

“Due to the ongoing epidemic of diabetes and cardiovascular disease, every year more and more patients are presenting with end-stage CLI, and the tools we have to treat them are limited,” commented Steven Kum, MD, Vascular Surgeon at Changi Hospital in Singapore. “The LimFlow System is a new and critically important option for patients who suffer substantially from their ischemic foot. This therapy will create a strong foundation for us as vascular specialists, working with a wound care team, to provide new hope for them.”

Designed to promote chronic wound healing and avoid major amputation, the LimFlow System offers a new percutaneous therapy option for patients who have exhausted all other revascularization methods. The system works by 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.

Both first-in-man and CE Mark clinical studies have been completed for the LimFlow System. Initial results have been presented at the Amputation Prevention Symposium and the Vascular International Advances Annual Conference. Journal publication of these results is expected soon.