FDA approves LimFlow system for patients with CLTI

Betsy Goodfellow | September 13, 2023 | News story | Medical Communications CLTI, Devices, FDA, LimFlow 

LimFlow SA has announced that the US Food and Drug Administration (FDA) has approved its LimFlow System for the treatment of patients with chronic limb-threatening ischemia (CLTI) who have no other suitable endovascular or surgical treatment options and are otherwise facing major amputation.

The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is intended to save patients’ legs from major amputation through restoring blood flow in deep veins for ‘no-option’ CLTI patients.

The FDA’s approval of the system follows positive outcomes seen in the PROMISE II trial, data from which was recently published in The New England Journal of Medicine. In this trial 76% of no-option CLTI patients were able to keep their legs, saw progressive wound healing, and many experienced significant pain relief following treatment.

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, US, commented: “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. 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.”

Dan Rose, LimFlow CEO, added: “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. We thank the FDA for their collaborative review process and we look forward to introducing and expanding use of the LimFlow System in the US.”

Betsy Goodfellow

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