Guidant Announces Positive Preliminary Results of Large Real-World Carotid Artery Stenting Study
Study Suggests Therapy Can Be Performed Safely by Broad Group of Physicians
INDIANAPOLIS & WASHINGTON, Oct. 20, 2005 -- Guidant Corporation (NYSE:GDT - News) today announced preliminary results of its study of carotid artery stenting in high-risk patients, called CAPTURE (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events). Results were presented today during the Late Breaking Registry Session at the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C. by Jay Yadav, M.D. from the Cleveland Clinic Foundation.
CAPTURE is an FDA-required post-approval study utilizing Guidant's carotid stent and embolic protection system. Key objectives of CAPTURE were 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 initial results of the study confirm positive earlier data on carotid stenting for high-risk patients. In addition, the study suggests that carotid artery stenting, which was introduced in the United States last year with the launch of Guidant's system, can be performed safely by physicians of different experience levels. The rate of death, stroke and myocardial infarction within 30 days of the procedure was 5.1 percent.
"CAPTURE is a landmark study. It is the largest and most rigorous real-world study of carotid stenting with independent neurologic follow up and clinical events adjudication. It demonstrates, for the first time, that with proper training carotid stenting can be performed with exemplary results by a variety of physicians in community hospital settings," said Dr. Yadav. "The excellent results and the overall ease of use of the system make this a breakthrough treatment for stroke prevention in high-risk patients."
Results were based on data from 1,603 patients receiving Guidant's FDA-approved
RX ACCULINK™ Carotid Stent System and RX ACCUNET™ Embolic Protection
System, which are indicated for high surgical risk patients. Patients in CAPTURE
were treated by 240 physicians, including interventional cardiologists, interventional
radiologists, interventional neuroradiologists, vascular surgeons and neurosurgeons,
at 118 hospitals in the United States. CAPTURE has enrolled more than 2,800 patients
to date and continues to enroll.
ARCHeR, the pivotal trial for the FDA approval of Guidant's carotid stent and embolic protection system, enrolled 581 patients at 48 centers with previous experience in carotid artery stenting. Results of the study demonstrated an 8.3 percent rate of death, stroke and myocardial infarction within 30 days of the procedure. ARCHeR enrollment was limited to high-risk patients. In addition to the CAPTURE and ARCHeR series of trials, Guidant is participating in the CREST trial evaluating carotid artery stenting in low-surgical risk patients, which continues to enroll.
"Guidant is committed to seeking innovative alternatives for the prevention and treatment of stroke, a devastating disease for patients and families and a tremendous burden to the U.S. healthcare system. And, we take seriously our leadership role in bringing carotid stenting to physicians and hospitals. In addition to our support of the clinical science with CAPTURE and ARCHeR and our involvement with the CREST trial, Guidant has taken a proactive approach to sharing physicians' real-world experiences with this new therapy, continually enhancing our products, and developing effective training programs," said Ron Lattanze, president, Guidant Endovascular Solutions.
Guidant's devices are available only to physicians with the appropriate training and prerequisite experience for performing carotid interventions. The company has worked closely with the FDA, medical societies and leading practitioners to develop targeted training programs in the use of the ACCULINK/ACCUNET Systems for physicians based on their experience level. More than 30,000 patients worldwide have been treated with Guidant's carotid stents.
About Carotid Artery Disease and Stroke
Stroke is the third leading cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. Approximately 25 percent of strokes are caused by carotid artery disease. Clogged carotid arteries can cause ischemic stroke, the most common type. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and 280,000 will die.
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. Driven by a strong entrepreneurial culture of 12,000 employees, 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.
Contact:
Guidant Corporation
Steven Tragash, Corporate Communications, 317-971-2031
Andy Rieth, Investor Relations, 317-971-2061
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