FDA approves LimFlow system for patients with CLTI
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.
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