FDA OKs LimFlow for Serious PAD, Device Reroutes Arterial Blood Via Veins

September 14, 2023

The US Food and Drug Administration (FDA) has approved an endovascular device for patients with chronic limb-threatening ischemia (CLTI) at risk for major amputation who are poor candidates for traditional revascularization, manufacturer LimFlow SA has announced.  

The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV), as the company calls it, can redirect flow from leg arteries into the venous system serving the distal limb and supply oxygen-rich arterial blood, for example, toa badly ischemic foot.

In the 105-patient single-arm PROMISE II multicenter trial that led to the FDA approval, the device created the artery-vein connection at a segment of the posterior tibial artery in 75% of cases and of the peroneal artery in another 19%.

By 6 months after the transcatheter procedure, 66% of these otherwise no-option CLTI patients met the primary endpoint of survival free of above-ankle amputation. That compares to the trial's prospectively defined performance goal of 54%. Limb salvage was achieved in 76% of cases.

PROMISE II was published online March 30 in the New England Journal of Medicine and covered then by theheart.org | Medscape Cardiology.

"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," states Daniel G. Clair, MD, in the company's press release. Clair is a PROMISE II co-principal investigator and chairs the department of vascular surgery at Vanderbilt University Medical Center, Nashville, Tennessee.

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