LimFlow, a developer of minimally-invasive technologies for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), has announced that the US 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.
The LimFlow system for transcatheter arterialization of deep veins (TADV) is designed to re-establish 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 Americans and disproportionately impacts minority and underserved patients, resulting in more than 150,000 major amputations per year in the US 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 (Vanderbilt University Medical Center, Nashville, USA), PROMISE II/III co-principal investigator. “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.
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 USA.”