FDA Approves Boston Scientific's Express(R) SD Renal Stent System

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Dec 2008 - 0:00 PST

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Boston Scientific Corporation announced that the U.S. Food and Drug Administration (FDA) has approved the Express® SD Renal Monorail® 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 to evaluate the safety and efficacy of the Express SD Renal Stent in hypertensive patients with atherosclerotic renal artery stenosis (RAS), demonstrated a statistically significant improvement in systolic blood pressure and no statistical difference in either diastolic blood pressure or serum creatinine levels from baseline through three years(1). Nine-month results demonstrated a binary restenosis rate of 21.3 percent (23/108), low target lesion revascularization (TLR) rates of 8.1 percent (9/111) and no stent thrombosis (0/100)(2).

The Express SD Renal Stent is designed specifically for treatment of the renal arteries by incorporating additional connections in the proximal end of the stent, which are intended to provide excellent support, especially in lesions occurring at the opening of the renal artery (ostial lesions). Based on Maverick® Monorail® Balloon Catheter technology and Tandem Architecture™ Stent Design, the Express SD Renal Stent is designed to provide strength, precision and deliverability.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.

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Boston Scientific Corporation