Guidant Begins Enrollment in European Drug Eluting Stent Study; Data From Study Will Support Launch of XIENCE V Coronary Stent S
06 Juillet 2005 - 9:54PM
Business Wire
Guidant Corporation (NYSE:GDT) today announced that the company has
begun enrollment in its SPIRIT II drug eluting stent clinical
study. SPIRIT II is a 300-patient study evaluating XIENCE(TM) V, an
everolimus eluting coronary stent system utilizing Guidant's cobalt
chromium MULTI-LINK VISION(R) Coronary Stent System platform. This
single-blind, randomized controlled study further evaluates the
XIENCE V compared to the TAXUS(R) Express 2(TM) Paclitaxel Eluting
Coronary Stent System for the treatment of coronary artery disease.
Results of the SPIRIT II study will provide additional clinical
data to support the launch of XIENCE V in several countries outside
the United States. "SPIRIT II will provide additional important
data about drug eluting stents for the treatment of coronary artery
disease, a growing cause of disability around the world," said John
M. Capek, Ph.D., president, Vascular Intervention, Guidant. The
first patient was enrolled by Gert Richardt, Prof., M.D., of
Segeberger Kliniken GmbH, in Bad Segeberg, Germany. "I am
enthusiastic about the potential of the XIENCE V everolimus eluting
stent system for the treatment of coronary artery disease," said
Prof. Richardt. "I look forward to the results from SPIRIT II,
which will provide additional data on this important therapy."
Guidant recently announced the U.S. initiation of SPIRIT III, a
large-scale pivotal clinical trial evaluating XIENCE V. Results of
the SPIRIT III trial may be used to obtain FDA approval for XIENCE
V for the treatment of coronary artery disease. 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(R) 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 study, associated
regulatory processes and timelines, and other factors identified on
Exhibit 99 to the company's most recent filing on Form 10-Q. Actual
results may differ materially. The company does not undertake to
update its forward-looking statements.
Guidant (NYSE:GDT)
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