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New Device to Treat Peripheral Artery Disease


The Food and Drug Administration (FDA) has approved a device that can suck up life-threatening plaque debris in people who have peripheral artery disease (PAD) in the legs. This new device can replace the current less efficient and less safe method of using filters to capture the particles.

Peripheral artery disease device has high success rate

Peripheral artery disease is a condition in which fatty deposits (lesions) accumulate in the inner linings of the artery walls. These plaque deposits limit blood flow, mainly in arteries that lead to the kidneys, stomach, arms, legs, and feet. Common symptoms during the early stages of the disease include cramping or fatigue in the legs and buttocks during physical activity.

In individuals with PAD for whom diet and other lifestyle changes are not sufficient, angioplasty can be performed. Angioplasty is a nonsurgical procedure in which a catheter with a deflated balloon on its tip is passed into the narrowed or blocked peripheral arteries in order to dilate them. A stent is then deployed to keep the artery open.

During an angioplasty, pieces of plaque can be knocked loose from the artery walls and travel in the bloodstream down the leg. Large particles can block the flow of blood and result in a distal embolization, which can lead to leg amputation or even be fatal.

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Currently, physicians use a filter device to capture the loose particles of plaque that are knocked off the walls of the arteries during the procedure. This approach can damage the arteries, and although it is a routine, use of filters is “off label.”

The FDA-approved device, Proteus®, is for angioplasties that treat peripheral artery disease in the legs. Two clinical trials that included a total of 123 patients resulted in a success rate of 97 to 99 percent in capturing plaque debris.

The new device operates like a standard angioplasty balloon, but when the physician deflates the balloon, the negative pressure sucks up the particles and traps them inside as the balloon retracts. “This is a much more simple and elegant approach than filter devices,” noted Dr. Robert Dieter of Loyola University Health System, an interventional cardiologist and vascular specialist who has used the device on patients at Loyola and Edward Hines VA Hospital.

Although the majority of patients who have peripheral artery disease can be treated with lifestyle modifications (e.g., stop smoking, control diabetes and blood pressure, exercise, follow a low-fat, low-cholesterol diet) and/or medication (e.g., antiplatelet and cholesterol-lowering drugs), angioplasty is necessary for others. The new device to capture debris during angioplasty is a significant and even life-saving advance for many patients.

American Heart Association
Loyola University