The transcatheter stent-like device diverts arterial flow to the lower-extremity venous system to treat 'no-option' patients with chronic limb-threatening ischemia.
The US Food and Drug Administration has approved an endovascular device for patients with chronic limb-threatening ischemia at risk for major amputation who are poor candidates for traditional revascularization, manufacturer LimFlow SAThe LimFlow System for Transcatheter Arterialization of Deep Veins , 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.
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.
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