Interventional device developer Cook Medical reported that the first U.S. patients in its international Zilver PTX Stent clinical trial were treated at Tri-City Medical Center in Oceanside, Calif. The Zilver PTX device is a new type of drug-eluting stent designed to prevent blockages in arteries outside the heart.
The Zilver PTX is a self-expanding nitinol stent, which 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.
The trial, being conducted at 28 U.S. location as well as Japan, is intended to evaluate paclitaxel-eluting stents in treating peripheral arterial disease (PAD), according to the Bloomington, Ind.-based Cook. Following successful safety testing during the trial's Phase I enrollment, Cook will enroll more than 700 patients in the trial that will be used to support submission to the U.S. Food and Drug Administration for approval to market the device.
The U.S. patients were treated by principal investigator Dr. Richard Saxon, assistant clinical professor of radiology at University of California, San Diego, as part of the clinical trial.