LimFlow System Earns FDA Nod for Chronic, Limb-Threatening Ischemia

LimFlow SA, developer of minimally-invasive tech to treat chronic limb-threatening ischemia (CLTI), has received U.S. Food and Drug Administration (FDA) approval for its LimFlow system to assist CLTI patients with no other suitable endovascular or surgical treatment options, and are facing major amputation.
 
The LimFlow system for transcatheter arterialization of deep veins (TADV) helps reestablish blood flow in deep veins for “no option” CLTI patients. The therapy was engineered to save patients’ legs from major amputation. According to this study, CLTI results in over 150,000 major amputations annually in the U.S.
 
LimFlow believes its LimFlow TADV system will help these patients have access to a minimally invasive treatment to give them a chance to save their limbs.
 
“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,” 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, told the press. “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.”
 
The company said FDA approval was based on PROMISE II trial outcomes showing that 76% of no-option CLTI patients were able to keep their leg and even had progressive wound healing, with many having significant pain relief during the time following LimFlow treatment.
 
LimFlow says its system is the first, only FDA-approved TADV device. It previously earned FDA breakthrough device status and has been the subject of several studies.