Guidant Receives Approval to Begin U.S. Drug Eluting Stent Trial
05 Mai 2005 - 3:09PM
Business Wire
Guidant Corporation (NYSE:GDT) today announced that it has received
Investigational Device Exemption (IDE) conditional approval from
the U.S. Food and Drug Administration (FDA) to begin the U.S.
portion of its SPIRIT III clinical trial. SPIRIT III is 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(TM) V, an everolimus eluting
coronary stent system utilizing Guidant's cobalt chromium
MULTI-LINK VISION(R) Coronary Stent System platform, versus the
TAXUS(R) Express 2(TM) Paclitaxel Eluting Coronary Stent System.
Results of the SPIRIT III trial may be used to obtain FDA approval
for XIENCE(TM) V for the treatment of coronary artery disease.
Guidant expects to begin its SPIRIT II and III clinical trials in
the near future. "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(TM) V," said Dana G.
Mead, Jr., president, Vascular Intervention, Guidant. "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(R)-based platform." Guidant's
presence in U.S. drug eluting stents was achieved in February 2004
through an agreement with Cordis Corporation, a Johnson &
Johnson company. Under the terms of the agreement, Guidant
co-promotes Cordis' CYPHER(TM) Sirolimus-eluting Coronary Stent in
the United States. Guidant Corporation pioneers lifesaving
technology, giving an opportunity for better life today to millions
of cardiac and vascular patients worldwide. The company, driven by
a strong entrepreneurial culture of more than 12,000 employees,
develops, manufactures and markets a broad array of products and
services that enable less invasive care for some of life's most
threatening medical conditions. For more information visit
www.guidant.com. NOTE TO MEDIA: For more information about Guidant,
including its products and services, please visit the company's
newsroom at www.guidant.com/newsroom. This release includes
forward-looking statements concerning XIENCE(TM) V. The statements
are based on assumptions about many important factors, including
satisfactory enrollment and completion of the clinical trial,
associated regulatory processes and timelines, and other factors
identified on Exhibit 99 to the company's most recent filing on
Form 10-K. Actual results may differ materially. The company does
not undertake to update its forward-looking statements.
Guidant (NYSE:GDT)
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