Cordis Corporation Starts Pivotal Trial For ExoSeal(TM) Vascular Closure Device

Cordis Corporation, a
worldwide leader in developing and manufacturing interventional vascular
technology, announced today the start of the pivotal trial for the
ExoSeal(TM) Vascular Closure Device. The ECLIPSE Trial is a multicenter,
non-blinded, randomized study designed to measure the safety and efficacy
of the ExoSeal(TM) Vascular Closure Device versus manual compression to
close vascular access sites in patients having undergone diagnostic or
interventional procedures. The trial will encompass 400 patients from 18
medical centers across the United States.


On February 13, Principal Investigator Chiu Wong, M.D., Associate
Professor of Medicine, New York-Presbyterian Hospital/Weill Cornell Medical
Center and a Cordis Corporation Consultant, treated the first patient in
the trial. Prior to the start of the ECLIPSE Trial, the ExoSeal(TM)
Vascular Closure Device had been used in 150 patients participating in a
first-in-human study for the device.



"The results from the first-in-man study were very encouraging, and
this trial will help us determine whether those results can be maintained
in a larger number of patients," said Dr. Wong. "As an interventional
cardiologist, I welcome the opportunity to investigate a device that could
help patients recover faster from a catheterization procedure."



The ExoSeal(TM) Vascular Closure Device features a synthetic
bioabsorbable polymer and is being studied to determine whether it can
enable expedited hemostasis (the cessation of bleeding), faster patient
ambulation (ability to walk) and reduced bed-stay after a catheterization
procedure. It also represents Cordis' entry into the vascular closure
device market. Nearly eight million patients undergo cardiac
catheterization procedures annually.



"The swift progress of the ExoSeal(TM) Vascular Closure Device from the
proof-of-concept stage to a pivotal trial in only seven months marks a
major milestone in Cordis' efforts to accelerate the development of new
devices to improve the treatment of vascular diseases," said Campbell
Rogers, M.D., Chief Technology Officer, Cordis Corporation. "The ECLIPSE
Trial will help us evaluate whether the ExoSeal(TM) Vascular Closure Device
could make a significant and positive difference in patients' comfort as
well as recovery time following a catheterization procedure."



Catheterization procedures involve the temporary insertion of a
catheter into an artery, usually the femoral artery, through a vascular
puncture. While a variety of methods, such as manual compression, sandbags
and mechanical clamps have been used to close the puncture site and stop
the bleeding after the catheter is removed, many of these methods cause
significant discomfort and require several hours of bed-rest.



About Cordis Corporation



Cordis Corporation, a Johnson & Johnson company, is a worldwide leader
in developing and manufacturing interventional vascular technology. Through
the company's innovation, research and development, physicians worldwide
are better able to treat the millions of patients who suffer from vascular
disease. For more information, visit cordis.


Cordis Corporation

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