Guidant Receives FDA Approval for U.S. DES Trial

Guidant has received investigational device exemption conditional approval from the FDA to begin the U.S. portion of its SPIRIT III clinical trial, a large-scale pivotal clinical trial evaluating the safety and efficacy of Guidant's drug-eluting stent system for the treatment of coronary artery disease.

This prospective, randomized, single-blind trial compares Xience V, an everolimus-eluting coronary stent system using Guidant's cobalt chromium Multi-Link Vision coronary stent system platform, to the Taxus Express 2 Paclitaxel-Eluting coronary stent system. Results of the SPIRIT III trial may be used to obtain FDA approval for Xience V for the treatment of coronary artery disease.

"Guidant is pleased with this FDA conditional approval as it will allow the company to initiate the pivotal trial to evaluate the safety and efficacy of Xience V," said Dana Mead, Jr., president of Guidant Vascular Intervention. "We are excited to advance the science of drug-eluting stents by partnering with SPIRIT III investigators to generate new clinical data utilizing our Multi-Link Vision-based platform."