Interventional device developer Boston Scientific said it has begun clinical trial enrollment in studies evaluating its third-generation paclitaxel-eluting coronary stent, the Taxus Element stent. The Taxus Perseus clinical program will collectively enroll approximately 1,500 patients at 100 U.S. and international centers and will evaluate the efficacy and safety of the new stent in two studies.
The first study, the Taxus Perseus Workhorse study, will evaluate the safety and efficacy of the Taxus Element stent compared with the Natick, Mass.-based firm’s first generation drug-eluting stent, the Taxus Express2 stent.
The second study, the Taxus Perseus Small Vessel study, will compare the Taxus Element Stent to a historic control – Boston Scientific’s Taxus V de novo bare-metal Express coronary stent system.
The Taxus Element Stent features a proprietary platinum chromium alloy, designed to enable thinner struts, increased flexibility, and a lower profile while improving radial strength, recoil, and radiopacity, the vendor said. In addition, the device platform incorporates new balloon technology, intended to improve on Boston Scientific's Maverick balloon catheter technology, according to the company.