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

Guidant Corporation (NYSE:GDT) today announced that thefirst patient has been enrolled in a new post-approval study ofcarotid artery stenting in high surgical risk patients, called CAPTURE2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover RareEvents). A key objective of CAPTURE 2 is to gather additional and moreextensive clinical data to extend Medicare coverage of carotidstenting to a broader group of patients. The Guidant-sponsored studyutilizes Guidant's FDA-approved RX ACCULINK(R) Carotid Stent Systemand RX ACCUNET(TM) Embolic Protection System, which are indicated forhigh surgical risk patients. CAPTURE 2 will include up to 10,000patients at 400 U.S. centers.

CAPTURE 2 was developed following Guidant's first post-approvalstudy, CAPTURE. Data from CAPTURE 2 will provide a deeper and broaderunderstanding of carotid stenting in real-world clinical settings withphysicians who enter Guidant's training program with varying levels ofexperience, and will examine outcomes in both symptomatic andasymptomatic patients. The study will use an innovative electronicdata capture system to collect the rate of death, stroke andmyocardial infarction at 30 days following the procedure. Guidant willwork with Dartmouth Medical School and the Centers for Medicare andMedicaid Services (CMS) to potentially link to the Medicare databaseto collect one-year patient outcomes. An executive committee made upof physicians from multiple specialties will oversee the trial.

"CAPTURE 2, which will be the largest-ever study of thisbreakthrough therapy, is innovative in its approach. In addition tothe new technology that will be used to collect data and the potentialto link to the Medicare database to collect longer-term outcomes, thestudy's design and creation was the result of a unique collaborationbetween the clinical community, CMS, and the FDA," said Ron Lattanze,president, Guidant Endovascular Solutions. "The data from this studywill increase understanding of outcomes for patients with carotidartery disease, potentially leading to expansion of coverage to manymore patients at risk of stroke, a devastating condition that is atremendous burden to the U.S. healthcare system, patients andfamilies."

"The excellent results from CAPTURE and the overall ease of use ofGuidant's system make carotid stenting a breakthrough treatment forstroke prevention in high surgical risk patients," said Malcolm T.Foster III, M.D., director of Cardiovascular Research at BaptistHospital of East Tennessee in Knoxville, who enrolled the firstpatient in the study. "The initial results of CAPTURE demonstrated forthe first time that with proper training, carotid stenting can beperformed with excellent results by a variety of specially trainedphysicians in community hospital settings. CAPTURE 2 will provide aneven more extensive look at real-world results of carotid arterystenting."

Guidant's devices are available only to physicians withprerequisite experience and the appropriate training for performingcarotid interventions. The company has worked closely with the FDA,medical societies and leading practitioners from multiple specialtiesto develop targeted training programs for the ACCULINK/ACCUNET Systemsbased on experience level of the physician. More than 40,000 patientsworldwide have been treated with Guidant's carotid stent system.

About Guidant's CAPTURE Study

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

Guidant Corporation is a world leader in the treatment of cardiacand vascular disease. The company pioneers lifesaving technology,giving an opportunity for better life today to millions of cardiac andvascular patients worldwide. Guidant develops, manufactures andmarkets a broad array of products and services that enableless-invasive care for some of life's most threatening medicalconditions. For more information, visit www.guidant.com.