US FDA approves LimFlow system for treatment of CLTI

Vein becoming artery with LimFlow crossing stent

The US Food and Drug Administration (FDA) today announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic limb-threatening ischemia (CLTI).

LimFlow’s FDA approval follows New England Journal of Medicine publication of results from the PROMISE II multicentre prospective study, co-led by University Hospitals (UH) Harrington Heart & Vascular Institute (Cleveland, USA), which found that the therapy enabled most patients treated to keep their leg and experience wound healing.

Mehdi Shishehbor, president of UH Harrington Heart & Vascular Institute, and Angela and James Hambrick chair in Innovation, as well as lead author and co-principal investigator of the study, said: “LimFlow is a unique alternative to major amputation, providing hope to hopeless cases. The results from this study are excellent, and expanding LimFlow’s availability beyond the hospitals participating in the clinical study has the potential to save many more limbs and lives.”

A press release details that LimFlow takes a new approach to treating patients who are facing major amputation because they have no other suitable treatment options, such as traditional bypass surgery or endovascular revascularisation, due to extensive disease in the target arteries or other anatomical constraints. Using proprietary devices, the procedure essentially turns a vein into an artery. This shift rushes blood back into the foot.

Mehdi Shishehbor

The PROMISE II study evaluated 105 CLTI patients who were treated with transcatheter arterialisation of the deep veins (TADV) using LimFlow therapy. All patients had non-healing wounds on their feet and were facing inevitable amputation before the procedure. At six months post-procedure, the rate of limb salvage was 76%. Within the same time period, 76% of patients had completely healed or healing wounds. Freedom from all-cause mortality was 87% at six months.

“Although vascular disease has existed for decades, research and innovations in treatment options have been lacking,” said Shishehbor. “At UH Harrington Heart & Vascular Institute, we are proud to have led the research that showed the FDA that LimFlow works, so that patients have another option to keep their leg and improve their quality of life.”


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