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GAMC Using New Stent to Treat PAD

General PAD is characterized by reduced blood flow to the limbs. Doctors at GAMC are using the Zilver PTX Drug-Eluting Peripheral Stent, which is drug-coated and designed to help an artery in the upper leg (superficial femoral artery) stay open and unblocked from plaque. Although drug-coated stents have been used in coronary procedures for years, its use for treating the arteries of the leg is new.

The American Heart Association estimates that eight to 12 million people in the U.S. suffer from peripheral artery disease. PAD is a chronic, progressive circulatory disease in which plaque builds up and hardens, narrowing the arteries and limiting the blood flow to parts of the body. It typically affects arteries in the legs, but can affect blood flow to other parts of the body as well. It’s often treated with stents, but with most stents it is not a lasting solution. Often a re-narrowing of the artery occurs, known as restenosis. The use of Zilver PTX reduces this problem.

“We’re pleased to offer the Zilver PTX. This new kind of stent delivers medication to the narrowed area of the artery,” said Karen Brandt, vice president of Ancillary Services at GAMC. “We could see fewer patients returning to have their arteries opened again.” Doctors at GAMC began using the Zilver PTX stent on February 7. GAMC is one of a handful hospitals now using this new stent.

Zilver PTX is the first peripheral vascular device that combines the mechanical support of stents with the drug paclitaxel to reduce the risk of arteries re-narrowing. This is a significant step forward for the treatment of PAD because previous stents were made of metal without a drug coating. Zilver PTX both restores blood flow with a targeted delivery of the paclitaxel, which coats the stent without the use of a polymer. Zilver PTX is made of nitinol, a "shape memory" metal alloy, and is engineered to withstand the forces of the superficial femoral artery. The medication is slowly released over time to prevent the artery from re-closing.

PAD affects both women and men. Symptoms include pain in the legs, posterior, hip, thigh or calf that lessens with rest, though some patients with the condition have no leg pain, according to the U.S. Centers for Disease Control and Prevention. PAD is linked to smoking, hypertension, diabetes and other common conditions.

Clinical trials indicate that seven out of ten patients treated with Zilver PTX still had an open artery after two years compared to just three out of ten treated with angioplasty alone. The U.S. Food and Drug Administration approved the use Zilver PTX in the United States on November 15, 2012 for use in patients with the disease. The manufacturer selected Shands at the University of Florida’s Academic Health Center (UF), which was involved in clinical trials of the stent, to receive some of the first stents manufactured for public use. UF & Shands is one of 12 institutions nationwide initially approved to implant a new device for treatment of peripheral artery disease. UF vascular surgeons implanted UF & Shands’ first non-trial Zilver PTX stent in February.