Guidant (NYSE:GDT)
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Guidant Corporation (NYSE:GDT) today announced updated
results of 2,500 patients enrolled in its post approval study of
carotid artery stenting, called CAPTURE (Carotid ACCULINK/ACCUNET Post
Approval Trial to Uncover Rare Events). Results were presented today
during the Late Breaking Registry Session at the American College of
Cardiology meeting in Atlanta by William A. Gray, M.D., FACC, from the
Columbia University Medical Center in New York.
CAPTURE is an FDA-required post-approval study utilizing Guidant's
market leading carotid stent and embolic protection system. Key
objectives of CAPTURE are to determine whether carotid artery stenting
can be performed safely in real-world clinical settings with
physicians of varying levels of experience and to evaluate the
effectiveness of Guidant's training program.
The results of the study are consistent with and provide
confirmation of positive earlier CAPTURE data presented at the
Transcatheter Cardiovascular Therapeutics meeting in October 2005. The
study continues to suggest that carotid artery stenting in high
surgical risk patients can be performed safely by physicians of
different experience levels. The primary endpoint of 30-day death,
stroke and myocardial infarction is 5.7 percent. The rate of events
leading to significant disability or death (30-day major stroke and
death) is 2.5 percent.
"The large enrollment and excellent results of CAPTURE show that
carotid artery stenting has truly arrived as the treatment for
high-surgical risk patients with carotid artery disease at risk of
stroke," said Dr. Gray. "This landmark U.S. trial is the largest and
most rigorous real-world study of carotid stenting with independent
neurologic follow up and stroke event adjudication. The results
demonstrate that with proper experience levels and device training,
carotid stenting can be performed with exemplary results by a variety
of physicians in community hospital settings."
Results are based on a cohort of 2,500 patients treated with
Guidant's FDA-approved RX ACCULINK(TM) Carotid Stent System and RX
ACCUNET(TM) Embolic Protection System, which are indicated for high
surgical risk patients. Patients in CAPTURE were treated by 315
physicians, including interventional cardiologists, interventional
radiologists, interventional neuroradiologists, vascular surgeons and
neurosurgeons, at 137 hospitals in the United States. CAPTURE has
enrolled more than 3,700 patients to date and continues to enroll.
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.
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. For more information about carotid stenting,
including illustrations, fact sheets and an animation, please visit
www.guidant.com/carotidmediakit.