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Boston Scientific to Begin European Clinical Trials on Vanguard III Endovascular Aortic Graft.


NATICK, Mass., May 22 /PRNewswire/ --

Boston Scientific Corporation (NYSE NYSE

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) announced today that it will initiate European clinical trials on its Vanguard III Endovascular Aortic Graft (EAG EAG - Extended Affix Grammar ) device. The trial, which will involve a total of 70 patients at 11 sites, will evaluate the safety and performance of the Vanguard III device. The company has obtained Ethics Committee approvals from study sites and has notified Ministries of Health.

Boston Scientific has long pioneered the field of endovascular abdominal aortic repair. The device is a third-generation design that is based on extensive clinical experience. The new design includes modifications to the stent graft implant that are intended to address key clinical concerns, most specifically durability and device kinking associated with aneurysm aneurysm (ăn`yrĭzəm), localized dilatation of a blood vessel, particularly an artery, or the heart.  morphology changes. The device has demonstrated significant improvements over earlier generation devices in in vitro testing.

Paul LaViolette, President, Boston Scientific International, noted that long-term durability is a key concern in stent graft systems. "We believe that the design modifications will provide improved durability and potency as the aorta morphology changes over time. Physicians who have seen the prototypes and test data have been enthusiastic about the improvements."

Boston Scientific will immediately begin enrolling patients in the trial. The Vanguard III EAG is planned for full release in selected European countries later this year pending successful outcome of the clinical trial. A U.S. investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  will soon be submitted to the FDA.

Boston Scientific is a worldwide developer, manufacturer, and marketer of medical devices. The company's 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 inherent in product development, clinical investigation and commercialization of emerging technologies and other factors described in the company's filing with the Securities and Exchange Commission.
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Publication:PR Newswire
Date:May 22, 2000
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