GDT Guidant Corp

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.