GDT Guidant Corp

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.