Nonsurgical Therapy Avoids Leg Amputation

In a new study of 22 patients whose leg arteries were clogged with plaque, a nonsurgical therapy successfully cooled and opened the arteries, avoiding almost-certain amputation.

The therapy is designed to treat patients with peripheral artery disease (PAD), common in diabetics. PAD can reduce blood flow to the legs and feet, putting patients at risk for infection, leg ulcers, gangrene, and amputation. PAD is a strong risk factor for stroke.

The study of 22 patients offers the first results from a multicenter study at 30 U.S. hospitals enrolling 100 patients who were facing amputation of a foot or leg within six months. The patients were treated with CryoPlasty therapy, a below-the-knee procedure that uses nitrous oxide to inflate a balloon, cools it to -10oC, and then delivers it to an artery by a small catheter. After nine months, 83% of the treated arteries remained open. Typically, 59% of blocked vessels treated with traditional angioplasty remain open after one year.

The system for delivering the CryoPlasty therapy is called PolarCath, which was developed by CryoVascular Systems, Inc. (Los Gatos, CA, USA; www.cryoinc.com). The preliminary data on the 22 patients were presented at the annual International Symposium on Endovascular Therapy in Miami (FL, USA) in January 2005.

"Previously, amputation was the only option for some people with such advanced disease in arteries below the knee, many of whom were diabetic,” explained James D. Joye, D.O., director of the cardiac catheterization lab at El Camino Hospital (Mountain View, CA, USA) and co-inventor of the CryoPlasty technique. "CryoPlasty is a ‘no-harm' treatment that offers early, conservative management and can be used repeatedly--not only avoiding or delaying amputation but postponing the use of more-invasive procedures.”




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