Sep 2, 2004
Guidant Commends CMS Proposed Coverage of Carotid Artery Stenting In Post-Approval Studies

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE: GDT) today commended the Centers for Medicare & Medicaid Services (CMS) for its intent to expand coverage of carotid artery stenting to include patients receiving FDA-approved carotid stents as part of an FDA-required post-approval study. On Tuesday, the U.S. Food and Drug Administration (FDA) approved Guidant''s RX ACCULINK(tm) Carotid Stent System and RX ACCUNET(tm) Embolic Protection System. The new devices will provide a minimally invasive treatment alternative to conventional open carotid artery surgery to patients who are at high surgical risk.

"We are extremely pleased that the FDA and CMS worked together to enable greater access to this new therapy for Medicare beneficiaries," said Beverly Huss, president, Endovascular Solutions, Guidant Corporation. "The agencies'' timely action will benefit patients with carotid artery disease by accelerating our understanding of best clinical practices in a variety of settings."

Guidant''s post-approval studies will include at least 1,500 patients. These studies will provide for the collection of data on the ACCULINK Carotid Stent System and the ACCUNET Embolic Protection System when used by a broad group of physicians. Guidant''s devices will be available only to physicians with the appropriate training and experience for performing carotid interventions. The company has worked closely with the FDA, medical societies and leading practitioners to develop targeted training programs for physicians based on experience and skill level with carotid artery stent procedures.

Previously, CMS only covered carotid artery stenting in clinical trials of investigational products not yet approved by the FDA.

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.