U.S. Patients Treated with New Drug-Coated Stent – First international study of paclitaxel-coated stent for use outside the heart
July 16, 2007
Bloomington, IN – July 16, 2007 – The first U.S. patients in the pivotal Phase II trial of a potentially revolutionary new type of drug-coated stent designed to prevent blockages in arteries outside the heart were treated at Tri-City Medical Center in Oceanside, Calif., Cook Medical announced today. The patients were treated by principal investigator Dr. Richard Saxon, assistant clinical professor of radiology at University of California, San Diego, as part of the international Zilver PTX Stent Trial.
The trial is intended to evaluate paclitaxel-eluting stents in treating peripheral arterial disease (PAD), a serious medical condition that affects more than 10 million Americans each year. The study will determine if the same type of drug-eluting technology found in popular drug-coated stents used to treat blockages in the coronary arteries can be used to treat blockages in arteries outside the heart. Following successful safety testing during the trial's Phase I enrollment, Cook will enroll 480 patients in the Phase II trial that will be used to support submission to the U.S. Food and Drug Administration for approval to market the device.
"Drug-eluting stents that combine a metal scaffold with a drug were first applied in the heart, and the results have been very good," said Dr. Saxon. "Currently, drug-eluting stents are the primary therapy for obstruction in the coronary circulation. And it is hoped similar technology, used in the legs, will help those who suffer from peripheral arterial disease."
The Zilver PTX Stent Trial is being conducted at 28 U.S. locations and is the first medical device trial ever conducted simultaneously in the U.S. and Japan. Clinical data collected on Japanese and U.S. patients will be combined for the final evaluation of the device and used for regulatory submissions in both markets for approval. The trial will enroll patients who will be randomized to receive either the Zilver PTX stent or balloon angioplasty.
"Bringing together converging technologies, like devices with pharmaceuticals in the case of Zilver PTX, is a critical step in developing new advanced medical devices to treat many particular patient populations," said Rob Lyles, vice president and global leader of Cook Medical's peripheral intervention division. "At Cook, we are continuously driving to improve the quality of our products and in turn, improve the quality of patient outcomes."
Cook Medical's Zilver PTX, a self-expanding nitinol stent, uses a proprietary, polymer-free technology to coat the device with paclitaxel, an antiproliferative drug that has been used successfully to reduce the risk of renarrowing of arteries following angioplasty. In many cases, PAD patients who have been treated with balloon angioplasty and stenting experience restenosis, or renarrowing of the arteries, over time and must undergo more invasive treatment such as bypass surgery to reopen the arteries. The Zilver PTX trial will determine whether the combination of the stent and paclitxel will keep arteries open over time.
Peripheral Artery Disease (PAD) affects blood vessels that lead from the heart to other areas of the body, such as the legs, feet and kidneys. When the blood vessels become blocked due to the build-up of fatty deposits, blood circulation is restricted. Untreated, PAD results in pain when walking and can lead to gangrene and amputation.
About Cook MedicalCook Medical was the first company to introduce interventional devices in the United States. Today, the company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year for 2006 from Medical Device and Diagnostic Industry magazine. For more information, visit www.cookmedical.com and for more information about the trial, go to www.zilverptxtrial.com.