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Boston Scientific Receives CE Mark Approval for New Apex(TM) PTCA Dilatation Catheters
Paris (ots/PRNewswire) -
- New Design Offers Greater Flexibility in the Management of Patients With Complex Atherosclerosis
Boston Scientific Corporation (NYSE: BSX) announced today that the Apex(TM) Monorail and Over-The-Wire (OTW) PTCA dilatation catheters have received CE Mark approval. Both Monorail and OTW catheters are available in two designs to provide European physicians with further options for managing patients with complex atherosclerosis (blockage of the arteries).
Apex is a high-performance balloon catheter that allows physicians to reach and cross the most challenging atherosclerotic lesions. Designed for use with drug-eluting stents, Apex has been developed specifically to address physicians' need for a catheter that can reach not only the furthest blockages but also cross particularly tight or complex lesions.
Dr Marie-Claude Morice, head of the Institut Cardiovasculaire Paris Sud, France, was the first clinician to use catheters from the new Apex product line. "Apex PTCA dilatation catheters performed well during intervention procedures," she said. "The catheters are easy to guide through vessels and can cross lesions efficiently. I welcome innovative designs like Apex, which should benefit patients by minimising trauma and helping to reduce procedure time."
Apex represents a totally new strategy in balloon catheters, giving today's physicians the technology they need to treat complex lesions. Both Apex Monorail and OTW catheters are available in two different 1.5 mm designs, "Apex 1.5 mm Push" and "Apex 1.5 mm Flex". Apex Push offers optimal pushability for tight lesions, while Apex Flex provides excellent performance for the most tortuous arteries. The dual Apex 1.5 mm balloon catheter designs enable physicians to select the appropriate catheter based on the clinical situation.
"Achieving CE Mark approval is an important step for Apex," said Jeff Goodman, President of Boston Scientific International. "As a leader in the field of cardiovascular device technology, Boston Scientific listened and responded to physicians' requests for improvements to existing catheters. We are delighted to offer this highly innovative device that addresses physicians' needs for treating the most difficult and tortuous coronary lesions."
PTCA dilatation catheters are used to open up arteries blocked by atherosclerosis, which if left untreated can cause heart attacks and strokes by stopping blood from reaching the heart muscle and brain. Coronary heart disease by itself is the single most common cause of death in Europe, accounting for 1.95 million deaths in Europe each year(1).
Apex is the latest technological development by Boston Scientific to improve the management of patients with coronary atherosclerosis undergoing percutaneous coronary intervention (PCI). Boston Scientific enables PCI optimisation through a broad range of devices, including ultrasound imaging to assess lesions and balloon catheters and drug-eluting stents to reopen blocked arteries. This broad portfolio of devices enables physicians to achieve safe and effective outcomes for their patients.
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.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of 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, product performance, competitive offerings, and our market position. 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; 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 IA- 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 thereafter. 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.
Notes For Editors
Arteries become blocked as a result of a process called atherosclerosis ('hardening of the arteries'), in which the arteries become blocked by a build-up of fatty deposits (termed 'plaque'). Plaque is made up of fat, cholesterol, calcium and other substances found in the blood. As it grows, the build-up of plaque narrows the inside of the artery and, in time, may restrict blood flow to the heart or the brain leading to heart attack or stroke.
Blocked arteries can be opened by insertion of a catheter (which is a thin flexible tube) into the artery (the catheter is actually inserted into the patient's femoral artery in the groin and guided along the arterial system to the site of the blockage) and inflation of a tiny balloon at the tip of the catheter to stretch the artery. When the catheter is removed a tiny rigid tube, or stent, is left in the artery to keep it open. Rates of stent placement vary widely but approximately 500 stents are inserted per million population in Europe(2).
The CE Mark (Conformité Européenne, or European conformity) is a visible declaration by a manufacturer that the equipment complies with all applicable European Union directives on health and safety. This mandatory mark allows manufacturers and exporters to circulate products freely within European Union member countries.
(1) British Heart Foundation Heartstats. http://www.heartstats.org/datapage.asp?id=754 (last accessed 19 April 2007).
(2) British Heart Foundation Heartstats. http://www.heartstats.org/temp/ESspTabsp3.2spweb05hs1hs.xls (last accessed 19 April 2007).
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