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Boston Scientific Announces FDA Clearance of Products to Treat Malignant Gastrointestinal Obstructions.

NATICK, Mass., Nov. 27 /PRNewswire/ --

Boston Scientific Corporation (NYSE: BSX) today announced Food and Drug Administration clearance of two stent products for the treatment of malignant obstructions associated with gastrointestinal diseases. The Unistep Plus(TM) Wallstent(R) Enteral Endoprosthesis is cleared for relief of malignant obstructions of the colon and duodenum as well as a "bridge to surgery" -- an alternative to temporary surgical colostomies associated with malignant colonic strictures. The Unistep Plus(TM) Permalume Covered Biliary Wallstent(R) is cleared for palliating malignant obstructions of the bile duct. Both products are immediately available from the company's gastrointestinal endoscopy division, Boston Scientific/Microvasive.

The Unistep Plus Wallstent Enteral Endoprosthesis is the only product cleared by the FDA for both duodenal and colonic indications. It is also the first enteral stent to be cleared as a bridge to surgery for patients with malignant colonic obstructions, enabling patients to avoid a temporary colostomy when surgery is indicated. The system features a new delivery system with a braided outer catheter that allows the stent to be repositioned prior to deployment. It is currently available in the United States, Europe, Canada and Australia.

Approximately 130,000 new cases of colon cancer are diagnosed each year in the United States, and up to 30% of these patients will experience a partial or complete colonic obstruction due to a tumor blocking the colon or squeezing it shut. In those cases, a temporary colostomy is usually required to remove or bypass the blockage until surgery can be performed. This procedure connects the colon to a stoma (opening) in the side of the body, allowing solid waste to leave the body and empty into a bag.

The enteral stent allows physicians to palliate both duodenal and colonic obstructions and allows patients to avoid a temporary colostomy when surgery is indicated. In this stent procedure, no incision is needed to provide relief from the symptoms of a blocked colon, and the procedure allows additional time for physicians and patients to plan for the best method of treating the underlying malignancy. In addition to avoiding the trauma and risk of a temporary colostomy, patients who undergo the stent procedure won't suffer the potentially lengthy follow-up that is required to heal a stoma once the colostomy is removed after surgery is completed. This stent opens passageways, relieving painful symptoms of obstruction, and improves the quality of life for patients who are not able to undergo surgical procedures.

"This minimally invasive stent procedure offers a safe, less painful and less embarrassing treatment alternative for people who are suffering from a painful colonic obstruction and may be facing a temporary colostomy," said Alan Thorson, M.D., Associate Professor of Surgery, Section of Colon and Rectal Surgery, Creighton University, School of Medicine, Omaha, Nebraska. "The stent procedure dramatically reduces the risk involved in relieving the obstruction and decreases the time patients need to stay in the hospital when compared to surgery."

The Unistep Plus Permalume Covered Biliary Wallstent is the first commercially available covered metal biliary stent. Its new stent covering may reduce tissue in-growth that leads to the incidence of premature stent occlusion. This could minimize complications and reduce the likelihood of additional interventions. Approximately 40,000 patients in the United States and 120,000 patients worldwide suffer from malignant obstructions of the bile duct. The Covered Biliary Wallstent is currently available in the United States, Europe, Canada and Australia. Japanese market approval is expected soon.

"The FDA clearance of these two important products reinforces Boston Scientific's continued leadership in the treatment of gastrointestinal disease," said Greg Barrett, President, Boston Scientific/Microvasive. "The clearance of these products shows our commitment to technological progress for the treatment of pancreatic and biliary cancer. Our work with leading experts in the field has enabled us to develop these less invasive alternatives for gastrointestinal diseases that will greatly improve patient care and dramatically reduce costs."

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

This press release contains forward-looking statements. The Company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks inherent in commercialization of emerging technologies, physician acceptance of new products, regulatory approvals, competitive offerings and other factors described in the Company's filings with the Securities and Exchange Commission.
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Date:Nov 27, 2000
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