Medical device maker
received regulatory approval to expand a pivotal safety and efficacy trial of a new stent, the company announced after the close Wednesday.
Food and Drug Administration
initially awarded Guidant conditional investigational device exemption approval to begin the Spirit III drug-eluting stent clinical trial with a limited number of sites. To date, 117 patients have been enrolled.
Wednesday's FDA approval allows the company to expand enrollment in the U.S. portion of the clinical trial to the full cohort of 1,292 patients at up to 80 sites, the company says.
The Spirit III trial evaluates Guidant's Xience V stent, a wire mesh tube coated with the drug everolimus, to be implanted in a diseased coronary artery to keep it from clogging. The stent system uses Guidant's cobalt chromium Multi-Link Vision coronary stent platform.
The prospective, single-blind trial will compare the safety and efficacy of Xience V with
Taxus Express 2 paclitaxel-eluting coronary stent. Results of the Spirit III trial will be used to seek FDA approval for Xience V for the treatment of coronary artery disease.
In regular trading Wednesday, Guidant shares fell 5 cents to $71.65, while Boston Scientific climbed 1.7% to $26.38.