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"Recently revised treatment guidelines by the American College ofCardiology have recommended the use of embolic protection devices whentreating patients with SVG disease(1)," said Hank Kucheman, Senior VicePresident and Group President, Cardiovascular for Boston Scientific. "Untilnow, a filter-based solution smaller than 3.0 mm was not available for SVGs,which meant a significant patient population went underserved. By introducingthis smaller size, Boston Scientific now makes it possible for physicians tomeet this standard of care in a broader range of SVG vessels."
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The FilterWire EZ System is a low-profile embolic protection device thathas been clinically proven to capture and remove embolic material, leading toreduced complications during balloon angioplasty and stenting procedures inSVGs(2). SVG disease occurs in patients who have previously had coronaryartery bypass graft (CABG) surgery in which a vessel harvested from thepatient's leg is surgically attached to the arteries of the heart. Blood isredirected through the surgically attached SVG, bypassing the blocked arteryand increasing blood flow to the heart.
The complex nature and progression of SVG disease as compared to nativecoronary artery disease can create a challenging treatment situation forphysicians and a higher risk for patients. In Boston Scientific's BLAZE IIstudy, which evaluated the safety and performance of the FilterWire EZSystem's 2.25 - 3.5 mm size, a 30-day major adverse cardiac event (MACE) rateof 4.6 percent was reported, with MACE defined as death, myocardialinfarction, emergent CABG or revascularization. The study also resulted in nodeaths, no target lesion revascularizations (re-interventions) and no sub-acute thrombosis (clots) during the 30-day follow-up period. The BLAZE IIstudy involved 131 patients in 16 sites in the United States.
"Despite the complexity of treating smaller vessel SVGs, this studypresented excellent safety and efficacy data," said Kucheman. "That shouldgive physicians great confidence when treating the unpredictable SVGs they seein their practice every day."
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com .
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaningof Section 21E of the Securities Exchange Act of 1934. Forward-lookingstatements may be identified by words like "anticipate," "expect," "project,""believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates usinginformation available to us at the time and are not intended to be guaranteesof future events or performance. These forward-looking statements include,among other things, statements regarding clinical trials, regulatoryapprovals, competitive offerings, product performance and our market position.If our underlying assumptions turn out to be incorrect, or if certain risks oruncertainties materialize, actual results could vary materially from theexpectations and projections expressed or implied by our forward-lookingstatements. These factors, in some cases, have affected and in the future(together with other factors) could affe
