Healthcare Industry News: Boston Scientific
News Release - May 6, 2011
Boston Scientific Begins International Launch and First Implants of Next-Generation Devices to Treat Heart Failure and Sudden Cardiac DeathWorld's smallest and thinnest high-energy CRT-Ds and ICDs offer new features to optimize patient management
NATICK, Mass., May 6, 2011 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE:BSX ) today announced the launch and first implants of its ENERGEN™ and PUNCTUA™ cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) in Europe and other international markets. They are the world's smallest and thinnest high-energy devices to treat heart failure and sudden cardiac death and offer excellent longevity.
"These devices build on the technological advancements of COGNIS® and TELIGEN® by providing options to customize therapy for individual patients," said Professor Joachim Winter, M.D., who performed one of the first implants of the ENERGEN ICD with Dong-In Shin, M.D., at the University Hospital Dusseldorf in Germany. "The small profile, coupled with the 4-SITE™ connector system, allowed for an easy implant with a less pronounced physical appearance for the patient."
"Physicians and patients will truly appreciate the longevity of these devices since it may reduce the need for additional implant surgeries," said Peter Lecher, M.D., who performed one of the first implants of the ENERGEN CRT-D with Gunther Prenner, M.D., at the Medical University in Graz, Austria. "Additionally, the new therapy options, combined with the LATITUDE® Patient Management system, increase the variety of diagnostic parameters to help treat heart failure patients."
Most of the new ENERGEN and PUNCTUA devices offer the 4-SITE™ DF4 connector system option, designed to simplify the implant procedure and comply with international connector standards. Additionally, nearly all models are compatible with Boston Scientific's LATITUDE® Patient Management system, which enables physicians to remotely monitor implantable cardiac device patients between on-site office visits.
"The ENERGEN and PUNCTUA devices are designed to improve the ability of physicians to deliver effective patient care," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "This new portfolio of products, built on our tradition of innovation, continues our advantages in size, shape and longevity and provides multiple therapy options to match specific patient needs."
The Company received CE Mark approval for its ENERGEN and PUNCTUA CRT-Ds and ICDs in October 2010. In the U.S., they are investigational devices, limited by applicable law to investigational use and not available for sale. The Company expects Food and Drug Administration approval for the devices in late 2011 or early 2012.
About Boston Scientific
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, regulatory approvals and compliance, clinical trials, product features and performance, technology and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; product performance; regulatory compliance; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Source: Boston Scientific
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