Boston Scientific Announces CE Mark Approval and First Implants for New Devices to Treat Heart Failure and Sudden Cardiac DeathBy Boston Scientific Corporation, PRNE
Thursday, November 18, 2010
NATICK, Massachusetts, November 19, 2010 - Boston Scientific Corporation (NYSE: BSX) today announced CE
Mark approval of its INCEPTA(TM), ENERGEN(TM) and PUNCTUA(TM) cardiac
resynchronization therapy defibrillators (CRT-Ds) and implantable
cardioverter defibrillators (ICDs). They are the Company's latest devices to
treat heart failure and sudden cardiac death.
These next-generation products are designed to advance patient
care with options to expand appropriate therapy, optimize ventricular pacing
and manage heart failure. They are the world's smallest and thinnest
high-energy devices and offer extended longevity over legacy platforms.
The first implants of INCEPTA(TM) ICDs and CRT-Ds occurred in
Berlin, Germany at the Deutsches Herzzentrum Berlin (Stephan Goetze, M.D.,
Professor of Medicine); Herne, Germany at the Katholisches Marienhospital
Herne (Hans-Joachim Trappe, M.D., Professor of Medicine); Linz, Austria at
the Krankenhaus der Elisabethinen Linz (Siegmund Winter, M.D.); and
Maastricht, The Netherlands at the Academisch Ziekenhuis Maastricht (An
Moens, M.D.). These initial implants are part of the NOTICE-HF study, which
will evaluate and document the performance of the devices before full
commercial launch, expected in the U.S., the Europe/Middle East/Africa region
and certain Inter-Continental countries in the first half of next year.
"These devices offer physicians and their patients more
options to customize therapy with new features designed to identify patient
risks, while improving pacing and simplifying the implant," said Dr. Goetze,
the Principal Investigator of the NOTICE-HF study.
"Boston Scientific looks forward to making these devices
available to physicians and their patients," said Hank Kucheman, Executive
Vice President and President of Boston Scientific's Cardiology, Rhythm and
Vascular Group. "This new portfolio of products, built on our tradition of
innovation, provides multiple therapy options designed to match specific
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:
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CONTACT: Geraldine Varoqui Boston Scientific Public Relations International +49-170-782-85-58 email@example.com
CONTACT: Geraldine Varoqui, Boston Scientific, Public Relations International, +49-170-782-85-58, varoquig at bsci.com
Tags: Boston Scientific Corporation, Massachusetts, Natick, November 19