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Boston Scientific Receives Approval For Drug-Eluting Stent Clinical Trial.


Business Editors

NATICK, Mass.--(BUSINESS WIRE)--May 15, 2001

Angiotech (Nasdaq:ANPI ANPI Angiotech Pharmaceuticals Inc. (Vancouver, BC, Canada)
ANPI Associazione Nazionale Partigiani d'Italia (Italian: National Association of Partisans) 
) (TSE See Tokyo Stock Exchange.

TSE

1. See Tokyo Stock Exchange (TSE).

2. See Toronto Stock Exchange (TSE).
:ANP ANP atrial natriuretic peptide.

ANP

atrial natriuretic peptide.

ANP Atrial natriuretic peptide, see there
.); Boston Scientific Corporation (NYSE NYSE

See: New York Stock Exchange
:BSX BSX Bermuda Stock Exchange
BSX Bandai Satellaview-X
BSX Bicycle Super-X (Cross) 
)

Boston Scientific Corporation (NYSE:BSX) today announced it has received approval from The Freiburg Ethics Commission International (FECI) to initiate another paclitaxel-coated coronary stent clinical trial.

The TAXUS III-ISR trial is a feasibility study "A Feasibility Study" is an episode of the original The Outer Limits television show. It first aired on 13 April, 1964, during the first season. It was remade in 1997 as part of the revived The Outer Limits series with a minor title change.  that will evaluate the safety of the NIR(TM) Conformer paclitaxel-coated coronary stent for the treatment of in-stent restenosis in up to 30 patients. Endpoints for the trial are 30-day major adverse cardiac events (MACE) and six-month angiographic and intravascular ultrasound (IVUS IVUS Intravascular ultrasound, see there ) follow-up.

Despite the significant improvement stents offer over traditional balloon angioplasty for the treatment of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , in-stent restenosis - the regrowth Re`growth´   

n. 1. The act of regrowing; a second or new growth.
The regrowth of limbs which had been cut off.
- A. B. Buckley.
 of diseased tissue into a previously stented artery - continues to be a serious challenge for clinicians. In-stent restenosis occurs after approximately 15-20 percent of all stent placements and can reach as high as 50 percent in complex lesions. Many patients with complex coronary artery disease suffer from in-stent restenosis. These higher-risk patients will be the focus of the TAXUS III-ISR study.

"The ability to dramatically reduce restenosis rates is at the heart of our drug-eluting stent program," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "This new study provides us an opportunity to understand how drug-eluting stents may help a higher-risk segment of the patient population by expanding their treatment options. It is a significant milestone in our program because it further develops our clinical experience with this technology."

Boston Scientific has performed extensive pre-clinical work in its drug-eluting stent program to understand the effects of the polymer that delivers the drug to the vessel wall, the effects of paclitaxel at various dose formulations, and the therapeutic mechanisms. This pre-clinical work also focused on ensuring patient safety prior to commencing clinical trials. The proprietary polymer has been shown to be vascular compatible and programmable in its ability to deliver paclitaxel at different rates. Paclitaxel, the active component of the popular chemotherapeutic agent Taxol(TM), has demonstrated promising results in pre-clinical studies for reducing the processes leading to restenosis.

Boston Scientific completed enrollment in its TAXUS I feasibility trial in February. Thirty-day MACE evaluation has been completed in all these patients with no adverse events. Six-month angiographic and IVUS follow-up is currently underway in this trial and will be completed in August.

The Company expects to initiate a third clinical trial before the end of the second quarter. The TAXUS II trial will be a global randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 study that will evaluate safety and performance of a paclitaxel-coated stent on a larger population base with de novo lesions. This data will support an application for the European CE Mark.

Boston Scientific has acquired worldwide co-exclusive rights from Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI; TSE: ANP) to use paclitaxel to coat its coronary stent products and other vascular and non-vascular products.

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 of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process and other factors described in the Company's filings with the Securities and Exchange Commission.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 15, 2001
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