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Boston Scientific Announces Market Approvals for Cutting Balloon Ultra2 Dilatation Device |
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Next-generation device receives FDA approval and European CE Mark
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NATICK, Mass., June 10 -- Boston Scientific Corporation (NYSE: BSX - News) announced today that it has received U.S. Food and Drug Administration approval and the European CE Mark for the Cutting Balloon Ultra2 microsurgical dilatation device. The Company will launch Monorail® and over-the-wire versions of the device in both markets immediately. The Cutting Balloon Ultra2 device represents the next-generation of the Company's Cutting Balloon product, a novel device for dilatation of lesions in coronary arteries. The device features tiny, longitudinally mounted atherotomes (microsurgical blades) that help reduce resistance of a lesion to expansion. The atherotomes create incisions that relieve stress in the artery as the balloon inflates, reducing the force necessary to expand the vessel. The device's proprietary fold mechanism shields the atherotomes and protects the vessel wall as the catheter is passed to and from the treatment site. The Cutting Balloon Ultra2 device combines the Company's Maverick2 balloon catheter technology with Bioslide coating and enhancements to the balloon and microsurgical blades. As a result, the Cutting Balloon Ultra2 device's blades are 25 percent more flexible, the enhanced tip provides for easier guidewire insertion while a newly applied laser bonding technique provides additional flexibility and crossability. These improvements are designed to provide clinicians with greater deliverability and trackability to resistant lesions. "The original Cutting Balloon device was developed to treat lesions that are resistant to conventional balloon angioplasty, but it was limited in its ability to access distal or tortuous lesions," said Paul LaViolette, Boston Scientific Senior Vice President and Group President, Cardiovascular. "The Cutting Balloon Ultra2 device takes advantage of the superior catheter handling of Boston Scientific's Maverick catheter shaft allowing the device to treat lesions previously unreachable with the original Cutting Balloon device." The Cutting Balloon Ultra2 is designed to be used as a stand-alone treatment for complex lesions or as a pre-dilatation device for the pre- treatment of lesions where stents will be placed. "Plaque modification is a particularly important consideration in the thoughtful utilization of a drug-eluting stent," said Magumi Taniuchi, M.D., Ph.D., an interventional cardiologist at Barnes Hospital in St. Louis. "The Cutting Balloon Ultra2 device allows for precision pre-treatment of the lesion, thereby enhancing stenting." The Cutting Balloon Ultra2 device is available in lengths of 6 and 15 mm and diameters from 2.0 to 4.0 mm. 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: www.bostonscientific.com. 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, commercialization of new technologies, third party intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.
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