FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

PARIS & SAN JOSE, Calif.–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation.

“We thank the FDA for their collaborative review process and we look forward to introducing and expanding use of the LimFlow System in the U.S.”

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The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is designed to reestablish blood flow in deep veins for “no-option” CLTI patients. The therapy is designed to save patients’ legs from major amputation, as limb loss is associated with significant complications, mortality, and deterioration of quality of life. CLTI affects up to four million Americans¹ and disproportionately impacts minority and underserved patients,² resulting in more than 150,000 major amputations per year in the U.S.³ FDA approval of the LimFlow System will enable these patients to have access to a minimally invasive treatment giving them a chance to save their limbs and improve their quality of life.

“With LimFlow, we now have an option for the sickest patients who were previously consigned to limb loss and the downward spiral that accompanies it,” said Daniel Clair, MD, PROMISE II/III Co-Principal Investigator, Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences. “Using this new treatment, we have seen many patients whose limbs have been saved, whose pain has been reduced or resolved, whose chronic wounds are healed or healing, and who can now look forward to happier and more active lives.”

FDA approval was based on successful outcomes seen in the PROMISE II pivotal trial, recently published in the New England Journal of Medicine, and from positive clinical results seen in earlier studies. In the PROMISE II study, 76% of no-option CLTI patients were able to keep their leg and experienced progressive wound healing, with many having significant pain relief during the time following LimFlow treatment.⁴

The LimFlow System is the first and only FDA-approved device for TADV and previously received Breakthrough Device Designation from the FDA.

“At LimFlow, our vision is to achieve great outcomes for patients suffering from CLTI. We developed a novel way to make a vein function as an artery with the goal of saving limbs, and by doing that, saving patients’ lives,” said LimFlow CEO Dan Rose. “We thank the FDA for their collaborative review process and we look forward to introducing and expanding use of the LimFlow System in the U.S.”

The LimFlow System is indicated for patients who have chronic limb-threatening ischemia (CLTI) with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

The LimFlow System received the CE Mark and is currently available commercially in Europe. The LimFlow System has not been approved for sale in Canada or Japan.

About Chronic Limb-Threatening Ischemia (CLTI)

CLTI is the most severe form of PAD and often occurs in patients suffering from diabetes, coronary artery disease, obesity, high cholesterol, and/or high blood pressure. Patients with CLTI 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. To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither option is feasible due to extensive disease in the target arteries or other anatomical constraints.

About LimFlow and the LimFlow System

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, the minimally invasive LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) bypasses permanently blocked arteries in the leg and foot and delivers oxygenated blood back into the foot via the veins. Restoring perfusion in the lower limbs may help resolve chronic pain, improve quality of life, enable wound healing, and prevent major amputation. Click here to view a video of how the LimFlow System for TADV works.

LimFlow is a private, venture-backed medical device company transforming the treatment of chronic limb-threatening ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease, kidney disease and an aging population. For more information, visit www.limflow.com.

1. Yost ML. CLI U.S. epidemiology supplement 2016. THE SAGE GROUP.
2. Kalbaugh CA, Witrick B, Sivaraj LB et al. Non‐Hispanic Black and Hispanic Patients Have Worse Outcomes Than White Patients Within Similar Stages of Peripheral Artery Disease. JAHA.2022 Jan 4;11(1): https://doi.org/10.1161/JAHA.121.023396.
3. Creager MA, Matsushita K, Arya S, Beckman JA, Duval S, Goodney PP, Gutierrez JAT, Kaufman JA, Joynt Maddox KE, Pollak AW, Pradhan AD, Whitsel LP. Reducing Nontraumatic Lower-Extremity Amputations by 20% by 2030: Time to Get to Our Feet: A Policy Statement From the American Heart Association. Circulation. 2021 Apr 27;143(17):e875-e891.
4. Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martínez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; PROMISE II Investigators. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. N Engl J Med. 2023 Mar 30;388(13):1171-1180.