The U.S. Food and Drug Administration (FDA) announced approval of a therapy giving thousands of patients hope for an alternative to amputation of their legs. LimFlow therapy is 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 a severe form of vascular disease known as chronic limb-threatening ischemia (CLTI).

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

Mehdi Shishehbor, DO, MPH, PhD, 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, says, “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.”

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 revascularization, due to extensive disease in the target arteries or other anatomical constraints. Using proprietary devices, the procedure essentially turns a vein, which returns blood to the heart, into an artery, which carries oxygen-rich blood from the heart throughout the body. This shift rushes blood back into the foot.

The Amputee Coalition of America estimates more than 500 patients undergo an amputation every day. The main cause of limb loss is vascular disease. CLTI represents the end stage of peripheral artery disease. Poor circulation in the limb causes open sores and skin infections that cannot be healed due to insufficient blood flow. The condition can lead to gangrene and extreme pain.

An estimated 2 million Americans may be living with CLTI, and for many with comorbidities like diabetes, traditional treatments may not be feasible or may have already been exhausted. For these patients with no other options, the limb begins to turn black and die, and amputation may become imminent. But while it’s a treatment for a dying limb, amputation brings its own troubles. Around 30% of amputees experience depression or anxiety. Amputees can have “phantom pain” in the missing limb that causes stabbing, burning, or shooting sensations. Nearly half of all patients with vascular disease will die within five years after amputation. That’s higher than the five-year mortality rates for breast cancer, colon cancer, and prostate cancer.

The PROMISE II study evaluated 105 CLTI patients who were treated with transcatheter arterialization 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, 76% of patients were able to keep their leg (also called limb salvage). 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,” says Dr 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.”

Featured image: UH Cleveland Medical Center. Photo: University Hospitals