Guidant (NYSE:GDT)
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Guidant Corporation (NYSE:GDT) today announced
enrollment of the first patient in a first-in-man clinical trial
designed to evaluate the safety of a fully bioabsorbable everolimus
eluting stent platform for the treatment of coronary artery disease.
The trial, called ABSORB, will enroll up to 60 patients in Belgium,
Denmark, France, New Zealand, Poland and The Netherlands.
"As the world's first clinical trial evaluating a fully
bioabsorbable drug eluting coronary stent, this initial implant marks
a significant milestone for Guidant. This study will lay the
foundation for our continued work toward offering a valuable
alternative to current drug eluting stent implants that reside
permanently in the treated coronary artery," said John M. Capek,
Ph.D., president, Vascular Intervention, Guidant Corporation. "We are
excited about our bioabsorbable drug eluting stent program, which is
aligned with Guidant's strategy of leveraging bioabsorbable
technologies to provide innovative site-specific therapy for the
treatment of heart disease."
The ABSORB trial will study the safety of bioabsorbable drug
eluting stents developed by Bioabsorbable Vascular Solutions, an
entrepreneurial subsidiary of Guidant Vascular Intervention
established in 2003 in the Silicon Valley. These stents are designed
to be fully absorbed by vascular tissue following the restoration of
blood flow and drug elution in patients with coronary artery disease.
Guidant has completed extensive preclinical studies on its
bioabsorbable stent, gathering data on safety, drug dosing, and the
mechanical properties of the stent. The ABSORB clinical trial is a
non-randomized study with an initial assessment of safety (MACE and
stent thrombosis rate) at six months and a follow-up period of five
years.
The first implant was performed by a team headed by Drs. John
Ormiston and Mark Webster at Auckland City Hospital, New Zealand. Dr.
Ormiston and Professor Patrick Serruys, of the Thoraxcenter, Erasmus
University Hospital, Rotterdam will serve as the study's co-principal
investigators.
"With patients receiving an ever-increasing number of coronary
stents in more challenging vessel anatomies, we need clinical
solutions that reduce the amount of permanent metallic stent platforms
being implanted, and provide for increased flexibility in monitoring
and treating patients over an extended period of time," said Dr.
Ormiston. "We are highly encouraged by the progress thus far with
Guidant's bioabsorbable technology, and look forward to further
exploring its potential as part of the ABSORB trial."
Guidant Corporation is a world leader in the treatment of cardiac
and vascular disease. The company pioneers lifesaving technology,
giving an opportunity for better life today to millions of cardiac and
vascular patients worldwide. Guidant 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. The statements
are based on assumptions about many important factors, including the
company's expectations concerning the clinical data that will result
from the trial, and other factors identified in Item 1A of 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.