Boston Scientific Receives FDA Clearance for
Flextome™ Cutting
Balloon® Dilatation Device
New device treats coronary blockages resistant to balloon angioplasty
Natick, Massachusetts, Sept. 16, 2005 -- Boston Scientific Corporation
(NYSE: BSX - News) announced today that it has received clearance from the U.S.
Food
and
Drug Administration (FDA) to market its Flextome™ Cutting Balloon® Dilatation
Device for the treatment of coronary artery blockages often resistant to conventional
balloon angioplasty. The Company plans to launch the product in the United States
immediately. The product received CE Mark in Europe in January 2005.
"We were very impressed with the new Flextome Cutting Balloon and its significant improvement in deliverability," said Antonio Colombo, M.D., Columbus Hospital and San Rafaelle Hospital in Milan, Italy. "The Cutting Balloon's unique and effective mechanism of action created by the use of atherotomes is very different from that of other dilatation devices, which use wires and balloons. The Flextome Cutting Balloon will help us achieve excellent outcomes in our angioplasties."
The Flextome Cutting Balloon Device consists of a new balloon with three to four
microsurgical blades (atherotomes) mounted lengthwise on its outer surface. When
the device is inflated, the atherotomes score the plaque by severing the elastic
and fibrotic continuity of the vessel with tiny incisions. This process allows
expansion of the target lesion with less pressure on the vessel wall and may
reduce trauma compared with standard balloon angioplasty. Internal testing performed
by Boston Scientific shows that the new Flextome Cutting Balloon is 30 percent
more deliverable than its predecessor, the Cutting Balloon® Ultra2™ Device,
due to several design improvements, including an improved atherotome design,
new balloon material and the use of the Maverick® catheter system.
Balloon angioplasty is often used to open blocked coronary arteries prior to the implantation of stents, small mesh tubes that help prevent the vessels from closing again. In many cases, coronary artery lesions are fibrous or otherwise resistant to compression by the angioplasty balloon. The Flextome Cutting Balloon makes resistant lesions easier to treat by scoring them with microsurgical blades.
"Boston Scientific understands that physicians need specialized devices to treat complex lesions," said Hank Kucheman, Boston Scientific Group President, Cardiovascular. "The Flextome Cutting Balloon Device has significant improvements that will help physicians' ability to treat these challenging cases."
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.
This press release contains forward-looking statements. Boston Scientific 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 new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
CONTACT:
Milan Kofol
508-650-8569
Investor Relations
Boston Scientific Corporation
Paul Donovan
508-650-8541
Media Relations
Boston Scientific Corporation
Source: Boston Scientific Corporation
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