Doctors routinely insert metal tubes, or stents, in heart arteries to restore blood flow, preventing heart damage and saving lives. Now, an advanced version of the minimally invasive therapy available in Europe is offering hope to millions of people with advanced peripheral arterial disease (PAD), a condition that blocks circulation to the legs and is a leading cause of amputation—especially among diabetics.
“Currently, blockages in the legs can be treated with angioplasty, bypass surgery, and with bare metal stents,” Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division, explains to the Post. “Data from a 1200-patient clinical trial, which included diabetics and other hard-to-treat patients, show that the new stent was as effective as bypass surgery, and without the risks associated with opening the leg.”
The Zilver PTX stent by Cook Medical props open the main blood vessel in the thigh—the superficial femoral artery. The stent then delivers the drug paclitaxel to cells in the vessel wall to reduce the risk of new blockages.
“The superficial femoral artery is difficult to treat because of the torque and flexing that takes place in the area as a result of normal movements like running, walking, or sitting,” Lyles says. “Zilver PTX uses a self-expanding metal called nitinol. The stent will move with the person—expanding when the artery expands, compressing when the artery compresses—which is an especially important feature for stents placed in the legs.”
In another key advance, the innovative device is the first drug-eluting stent free of a plastic compound linked to allergic reactions, clot formation, and inflammation.
PAD occurs when fatty deposits build up within the lining of the arteries and reduce blood flow. The most common symptom of PAD is leg pain during exercise. Severely reduced blood flow in the limbs (known as critical limb ischemia (CLI) is characterized by leg pain at rest and nonhealing wounds. Gangrene may lead to amputation of the leg or foot.
The Zilver stent, considered an investigational device in the United States, was approved this summer in Europe and is now being used in more than 50 countries.
“The awarding of the CE Mark is set to herald a revolution in the treatment of peripheral arterial disease,” comments lead study investigator Dr. Michael Dake of Stanford University Medical School in California. “The global study proves that the Zilver PTX has the integrity, safety, and durability needed to successfully address many of the well-known limitations of current treatments for the management of PAD.”
For information about ongoing U.S. studies of the Zilver stent for PAD, talk with your physician and visit zilverptxtrial.com.