Drug-eluting stent
From WikiCover
On July 18, 2007, Angiotech Pharmaceuticals and Cook Medical announced that the first U.S. patients in the pivotal approval trial of a potentially revolutionary new type of drug-eluting stent designed to prevent blockages in arteries outside the heart were treated at Tri-City Medical Center in Oceanside, California. 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 pivotal 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 over 700 patients in the pivotal trial that will be used to support submission to the U.S. Food and Drug Administration for approval to market the device.
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.
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 paclitaxel will keep arteries open over time.