FDA Greenlights LimFlow System for Chronic Limb-Threatening Ischemia Patients with Limited Revascularization Options

Wednesday, September 13, 2023

LimFlow SA, a trailblazing company in the realm of minimally-invasive technology for treating chronic limb-threatening ischemia (CLTI), a severe manifestation of peripheral artery disease (PAD), has obtained FDA approval for its LimFlow System. This marks a significant milestone for CLTI patients who have exhausted all other available endovascular or surgical treatment options and are confronting the dire prospect of major amputation.

The LimFlow System, designed for Transcatheter Arterialization of Deep Veins (TADV), has been meticulously crafted to reinstate blood flow in deep veins for individuals with CLTI who are classified as "no-option." The primary objective of this therapy is to stave off major amputations, given that limb loss is associated with grave complications, increased mortality rates, and a notable deterioration in the quality of life. CLTI afflicts a substantial number of Americans, with a disproportionate impact on minority and underserved communities, resulting in over 150,000 major amputations annually in the United States. The FDA's green light for the LimFlow System opens up new possibilities for these patients, offering them access to a minimally invasive treatment option that could potentially salvage their limbs and enhance their overall quality of life.

Dr. Daniel Clair, a Co-Principal Investigator of the PROMISE II/III trial and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center Section of Surgical Sciences, underscored the profound impact of this groundbreaking treatment. He cited cases where patients' limbs were preserved, pain was alleviated or resolved, chronic wounds exhibited healing or improvement, and their overall outlook on life took a positive turn.

The FDA's decision to approve the LimFlow System was underpinned by the favorable outcomes witnessed in the PROMISE II pivotal trial, which was recently featured in the New England Journal of Medicine, alongside positive clinical results from prior studies. In the PROMISE II trial, 76% of "no-option" CLTI patients retained their limbs and experienced ongoing wound healing, with many also reporting significant relief from pain following LimFlow treatment.

The LimFlow System holds the distinction of being the first and only FDA-approved device for TADV, having previously earned Breakthrough Device Designation from the FDA.

LimFlow CEO Dan Rose highlighted the company's overarching vision to deliver outstanding outcomes for CLTI patients. He emphasized their innovative approach, which involves transforming a vein into an artery with the aim of preserving limbs and, by extension, saving lives. Rose expressed gratitude to the FDA for their collaborative review process and expressed anticipation about introducing and expanding the utilization of the LimFlow System throughout the United States.
The LimFlow System is indicated for patients diagnosed with chronic limb-threatening ischemia (CLTI) who have exhausted all available endovascular or surgical revascularization options and face a significant risk of major amputation.

While the LimFlow System has secured the CE Mark and is commercially available in Europe, it has not yet received approval for sale in Canada or Japan.


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