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FDA Approves LimFlow, a Minimally Invasive Therapy Shown to Save the Legs of Severe Vascular Disease Patients from Amputation
Research led at University Hospitals demonstrated LimFlow therapy helped 76 percent of patients at risk for major amputation keep their leg
Research led at University Hospitals demonstrated LimFlow therapy helped 76 percent of patients at risk for major amputation keep their leg
CLEVELAND – The U. S. Food and Drug Administration (FDA) today 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, 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.”
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 two 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 percent 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 percent of patients were able to keep their leg (also called limb salvage). Within the same time period, 76 percent of patients had completely healed or healing wounds. Freedom from all-cause mortality was 87 percent at six months.
“Although vascular disease has existed for decades, research and innovations in treatment options have been lacking,” said 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.”
About University Hospitals / Cleveland, Ohio
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 21 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, the Technion Israel Institute of Technology and National Taiwan University College of Medicine. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org.
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