Guidant Announces Enrollment of First Patient in Landmark Carotid Artery Stenting Study; 10,000-Patient Study Aims to Further U

Guidant Corporation (NYSE:GDT) today announced that the
first patient has been enrolled in a new post-approval study of
carotid artery stenting in high surgical risk patients, called CAPTURE
2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare
Events). A key objective of CAPTURE 2 is to gather additional and more
extensive clinical data to extend Medicare coverage of carotid
stenting to a broader group of patients. The Guidant-sponsored study
utilizes Guidant's FDA-approved RX ACCULINK(R) Carotid Stent System
and RX ACCUNET(TM) Embolic Protection System, which are indicated for
high surgical risk patients. CAPTURE 2 will include up to 10,000
patients at 400 U.S. centers.
   CAPTURE 2 was developed following Guidant's first post-approval
study, CAPTURE. Data from CAPTURE 2 will provide a deeper and broader
understanding of carotid stenting in real-world clinical settings with
physicians who enter Guidant's training program with varying levels of
experience, and will examine outcomes in both symptomatic and
asymptomatic patients. The study will use an innovative electronic
data capture system to collect the rate of death, stroke and
myocardial infarction at 30 days following the procedure. Guidant will
work with Dartmouth Medical School and the Centers for Medicare and
Medicaid Services (CMS) to potentially link to the Medicare database
to collect one-year patient outcomes. An executive committee made up
of physicians from multiple specialties will oversee the trial.
   "CAPTURE 2, which will be the largest-ever study of this
breakthrough therapy, is innovative in its approach. In addition to
the new technology that will be used to collect data and the potential
to link to the Medicare database to collect longer-term outcomes, the
study's design and creation was the result of a unique collaboration
between the clinical community, CMS, and the FDA," said Ron Lattanze,
president, Guidant Endovascular Solutions. "The data from this study
will increase understanding of outcomes for patients with carotid
artery disease, potentially leading to expansion of coverage to many
more patients at risk of stroke, a devastating condition that is a
tremendous burden to the U.S. healthcare system, patients and
families."
   "The excellent results from CAPTURE and the overall ease of use of
Guidant's system make carotid stenting a breakthrough treatment for
stroke prevention in high surgical risk patients," said Malcolm T.
Foster III, M.D., director of Cardiovascular Research at Baptist
Hospital of East Tennessee in Knoxville, who enrolled the first
patient in the study. "The initial results of CAPTURE demonstrated for
the first time that with proper training, carotid stenting can be
performed with excellent results by a variety of specially trained
physicians in community hospital settings. CAPTURE 2 will provide an
even more extensive look at real-world results of carotid artery
stenting."
   Guidant's devices are available only to physicians with
prerequisite experience and the appropriate training for performing
carotid interventions. The company has worked closely with the FDA,
medical societies and leading practitioners from multiple specialties
to develop targeted training programs for the ACCULINK/ACCUNET Systems
based on experience level of the physician. More than 40,000 patients
worldwide have been treated with Guidant's carotid stent system.

   About Guidant's CAPTURE Study

   Guidant's post-approval CAPTURE study has enrolled more than 3,700
patients and continues to enroll. The initial results of CAPTURE
confirmed positive earlier data on carotid stenting for high surgical
risk patients. In addition, CAPTURE results suggested that carotid
artery stenting with Guidant's system can be performed safely by
physicians of varying levels of experience who meet the prerequisites
of Guidant's training program.

   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.