Image: The LimFlow CLI percutaneous system (Photo courtesy of LimFlow).
A fully percutaneous critical limb ischemia (CLI) system is designed to promote chronic wound healing and avoid major amputation.
The LimFlow (Paris, France) system provides a novel percutaneous therapy for end-stage CLI patients who are at eminent risk of limb amputation and who have exhausted all current revascularization options. The system uses proprietary ultrasound-guided catheters, one venous and one arterial, in order to install a crossing nitinol stent that creates an arterio-venous fistula (AVF) that bypasses diseased arteries and diverts blood flow into the tibial vein in order to vascularize the entire ischemic foot.
The venous ultrasound catheter is first advanced into the tibial vein, and the arterial ultrasound catheter is advanced into the tibial artery; after arriving at the occlusion site, the arterial ultrasound catheter is rotated until a peak ultrasound signal is achieved; the needle of the arterial ultrasound catheter is then advanced into the tibial vein. A standard guide wire is then installed through the crossing needle, which allows for the deployment covered nitinol stent, creating the AVF. Finally, after stent dilation, both catheters and the guide wire are removed.
“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,” said Dan Rose, CEO of LimFlow. “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.”
“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,” said Steven Kum, MD, a vascular surgeon at Changi Hospital (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.”
CLI is the most severe form of peripheral artery disease (PAD) and often occurs in patients suffering from coronary artery disease (CAD), 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.