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FDA Approves Blood Flow-Diverting LimFlow System for No-Option CLTI

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The basis for the approval was the successful results for deep-vein arterialization borne out in the PROMISE II trial.

The US Food and Drug Administration has approved the LimFlow self-expanding covered stent system for arterialization of deep veins in the foot in no-option patients with chronic limb-threatening ischemia (CLTI) who are facing major amputation, its manufacturer announced today.

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