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FDA Approves Boston Scientific's Express(R) SD Renal Stent System
Date:12/15/2008

NATICK, Mass., Dec. 15 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Express(R) SD Renal Monorail(R) Premounted Stent System for use as an adjunct to PTRA (percutaneous transluminal renal angioplasty) in certain lesions of the renal arteries. The Express SD System is the first low-profile, pre-mounted stent approved for use in renal arteries in the United States. It is the only FDA-approved renal stent designed to provide additional proximal end support.

"The approval of the Express SD Stent for renal indications provides physicians with an on-label stenting option for use with PTRA in certain patients with renal artery disease," said Krishna Rocha-Singh, M.D., F.A.C.C., of Prairie Cardiovascular Heart Institute in Springfield, Illinois.

"FDA approval for the Express SD Renal Stent is an important step in providing physicians evidence-based technology to facilitate the management of renal artery disease," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "With the addition of the Express SD Renal Stent, Boston Scientific can now offer customers the industry's leading portfolio of products for endovascular treatment of this disease."

Renal artery disease is the narrowing of the main blood supply to the kidneys due to atherosclerosis, or the formation of plaque within the arteries, which can lead to high blood pressure or poor kidney function. The disease can be treated surgically, with medication, or less invasively with angioplasty. Re-narrowing of the arteries can occur after angioplasty, and the use of stenting as an adjunctive treatment option is intended to assist in their re-opening.

Two-year results from the RENAISSANCE clinical trial, which was designed
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