New device treats coronary blockages resistant to balloon angioplasty
NATICK, Mass., Sept. 16 /PRNewswire-FirstCall/ -- Boston Scientific
Corporation (NYSE: BSX) announced today that it has received clearance from
the U.S. Food and Drug Administration (FDA) to market its Flextome(TM) Cutting
Balloon(R) 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(R) Ultra2(TM) Device, due to several design
improvements, including an improved atherotome design, new balloon material
and the use of the Maverick(R) 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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Related links:
http://www.bostonscientific.com
CONTACT:
Milan Kofol, +1-508-650-8569, Investor
Relations, or Paul Donovan, +1-508-650-8541, Media Relations,
both of Boston Scientific Corporation
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