A balloon angioplasty device that sucks up dangerous plaque debris could trigger a "paradigm shift" in how physicians treat peripheral artery disease, researchers write in the current issue of Endovascular Today.
"We will see a shift in how we treat lesions," write Dr. Robert Dieter of Loyola University Health System and Dr. Aravinda Nanjundappa of West Virginia University.
In two clinical trials totaling 123 patients, the device had a success rate of 97 percent to 99 percent and consistently outperformed filter devices typically used to capture debris particles, Dieter and Nanjundappa write.
The Food and Drug Administration has approved the device, Proteus, made by Angioslide, for angioplasties that treat peripheral artery disease (PAD) in the legs. PAD is caused by clogged arteries that restrict blood flow to the legs. Symptoms include painful cramping in the hips, thighs or calves when walking, climbing stairs or exercising. Advanced PAD can cause gangrene or even lead to limb loss.
A balloon angioplasty is among the standard treatments for PAD. A physician inserts a catheter in an artery and guides it to the blockage, then opens the artery by inflating a balloon at the tip of the catheter. The physician typically deploys a stent to keep the artery open.
Inflating the balloon can knock loose particles of plaque, which travel down the leg. A large particle can block blood flow, a condition called distal embolization. In the most severe cases, distal embolizations can require leg amputation or even be fatal.
Until now, some physicians have used a filter device to prevent debris from escaping. However, the filter can damage the artery, and can be difficult to deploy. Moreover the FDA has not approved filter devices for use in leg arteries. Using filters for PAD procedures, although routine, must be done "off label."
The new device that Dieter used opens the artery just like a standard angiopl
|Contact: Jim Ritter|
Loyola University Health System