A 45-year-old woman recently shared her story with me after finding our patient advocacy nonprofit The Way To My Heart and wishing she had found it sooner because we may have helped her save not just one leg but both. Two months after being diagnosed with Peripheral Artery Disease, a narrowing of mainly the leg arteries due to plaque build-up, her hospital vascular specialist told her that the vessels below her knee were severely compromised and too small to treat. He told her to walk until she couldn’t walk anymore and then he would amputate.
One night about six months later, she woke up at 2am because the pain was unbearable and she decided it was her leg or life. So, she and her husband drove to the emergency room where physicians pumped her full of powerful pain medications until her surgeon arrived and took her to the operating room to amputate her leg at the knee. She had never thought to get a second opinion as her vascular specialist was the head of the department at a large University Hospital. She thought he was the best and didn’t think to question his skillset until he gave her the same option for her left leg one year later. That’s when she found The Way To My Heart and we directed her to a “Pedal Loop Specialist” trained in navigating the small blood vessels below-the-knee to restore flow.
This woman’s story is not unique. Nearly 200,000 needless amputations are performed annually due to advanced stages of PAD, known as Critical Limb Threatening Ischemia. Navigating smaller, compromised vessels below-the-knee is risky and requires highly skilled interventionalists, special tools, and additional time, which are few and far between. New technology has the potential to change that. LimFlow has formalized a technique used by advanced interventionalists to re-route blood flow around a blockage in an artery below-the-knee using a vein. Arteries naturally deliver blood flow to the foot and veins are responsible for outflow. LimFlow’s system includes a specially designed crossing device to easily make the artery to vein connection. Forward flow is enabled in the vein through a disabling of the venous valves using a valvulotome. An extension stent is placed to block smaller veins from taking blood flow in the newly converted vein back to the heart, and a tapered crossing stent is used to bridge the artery to vein connection.
LimFlow’s CEO Dan Rose shares the backstory behind the system, which has already received CE Mark for use in Europe, and is well on it’s path to U.S. FDA clearance in the Q&A below.