New size allows for treatment of smaller-diameter diseased saphenous vein
NATICK, Mass., May 19 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the launch of its FilterWire EZ(TM) Embolic Protection System in a new 2.25 - 3.5 mm size, designed to contain and remove embolic material that may be dislodged during an interventional saphenous vein graft (SVG) procedure; otherwise, embolic material may travel into the microvasculature where it could pose an increased risk for a heart attack. The Company said the product would be available immediately.
"Recently revised treatment guidelines by the American College of Cardiology have recommended the use of embolic protection devices when treating patients with SVG disease(1)," said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. "Until now, a filter-based solution smaller than 3.0 mm was not available for SVGs, which meant a significant patient population went underserved. By introducing this smaller size, Boston Scientific now makes it possible for physicians to meet this standard of care in a broader range of SVG vessels."
The FilterWire EZ System is a low-profile embolic protection device that has been clinically proven to capture and remove embolic material, leading to reduced complications during balloon angioplasty and stenting procedures in SVGs(2). SVG disease occurs in patients who have previously had coronary artery bypass graft (CABG) surgery in which a vessel harvested from the patient's leg is surgically attached to the arteries of the heart. Blood is redirected through the surgically attached SVG, bypassing the blocked artery and increasing blood flow to the heart.
The complex nature and progression of SVG disease as compared to native coronary artery disease can create a challenging treatment situation for physicians and a higher risk for patients. In Boston Scientific's BLAZE II study, which evaluated the safety and performance of the FilterWire EZ System's 2.25 - 3.5 mm size, a 30-day major adverse cardiac event (MACE) rate of 4.6 percent was reported, with MACE defined as death, myocardial infarction, emergent CABG or revascularization. The study also resulted in no deaths, no target lesion revascularizations (re-interventions) and no sub- acute thrombosis (clots) during the 30-day follow-up period. The BLAZE II study involved 131 patients in 16 sites in the United States.
"Despite the complexity of treating smaller vessel SVGs, this study presented excellent safety and efficacy data," said Kucheman. "That should give physicians great confidence when treating the unpredictable SVGs they see in their practice every day."
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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CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation
(1) Smith SC Jr, et al., Circulation 2006; 113:156-175.
(2) Stone GW, et al., Circulation 2003; 108:548-553.
|SOURCE Boston Scientific Corporation|
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