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LimFlow Device Receives FDA Approval

Sep 20, 2023 |

Representing a significant breakthrough in amputation prevention, the LimFlow system was approved by the FDA on September 12, 2023. Monica Robins reported on the story for wkyc.   

LimFlow therapy is a minimally invasive procedure that bypasses blockages in arteries of the legs and restores blood flow using a vein for the blocked artery. It was developed by Dr. Mehdi Shishehbor, president of University Hospitals Harrington Heart & Vascular Institute in Ohio. The results published in the New England Journal of Medicine from the PROMISE II Multicenter Prospective Study helped secure approval. 

This procedure will give hope for an alternative to amputation for people with chronic limb-threatening ischemia (CLTI), a severe form of Peripheral Artery Disease (PAD). As September is PAD Awareness Month, the Amputee Coalition reminds you to know the facts about PAD and how to protect your limbs 

Now that LimFlow has gained FDA approval, it will be covered by insurance. “Because this is novel new technology, the Centers for Medicare and Medicaid Services (CMS) typically gives it a transitional pass-through, which means for two to three years, CMS will cover this and allow us to treat patients with whatever insurance that they have, Medicare, Medicaid and private insurance,” Dr. Shishehbor said. 

Learn more about LimFlow and if the LimFlow System is right for you by visiting their website.