Healthcare Industry News:  ultrasound catheter 

Devices Interventional Cardiology FDA Product Launch

 News Release - July 24, 2013

Boston Scientific Launches OptiCross(TM) Coronary Imaging Catheter in U.S., Europe and Japan

Next generation intravascular ultrasound catheter improves image quality and deliverability

NATICK, Mass., July 24, 2013 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (BSX) has received U.S. Food and Drug Administration clearance, CE Mark and Japan PMDA approval for its OptiCross™ Coronary Imaging Catheter and has launched the device in the U.S. and Europe. A launch in Japan is planned for later this month. OptiCross, a next generation intravascular ultrasound (IVUS) catheter, offers better deliverability and higher resolution imaging to facilitate complex coronary procedures.

Designed to be compatible with the Boston Scientific iLab® Ultrasound Imaging System, the OptiCross catheter was created with the input of physicians from around the world to reduce the inherent challenges surrounding catheter delivery in complex cases. The upgraded, low profile delivery system features 5 French guide catheter compatibility, a shorter, tapered tip, a bi-segmented catheter shaft and a redesigned catheter hub for ease of connection.

"The OptiCross catheter was designed for optimal deliverability and its performance proves it," said Matthew Price, M.D., interventional cardiologist and director of the Cardiac Catheterization Laboratory, Scripps Green Hospital, San Diego. "Now I can use IVUS technology in complex cases where I would not have been able to deliver an IVUS catheter before."

Interventional cardiologists use IVUS to see inside coronary arteries and to gain additional information in order to optimize treatment decisions.

"The OptiCross catheter widens the applicability of ultrasound with the ability to assess disease pre-procedure, without concern regarding ischemia and lesion trauma," said Dr. Neal Uren, clinical director for cardiac services at the Edinburgh Heart Centre, Royal Infirmary, Edinburgh. "The incremental increase in deliverability widens the use of IVUS into more difficult lesion subsets, while maintaining superior image quality."

The benefits of IVUS-guided percutaneous coronary intervention (PCI) were reinforced at TCT 2012 and at EuroPCR in May with the presentation of the ADAPT-DES IVUS sub-study outcomes. The results showed that IVUS can help improve patient outcomes and change the way physicians approach their cases.

"The OptiCross catheter demonstrates Boston Scientific's commitment to advancing intravascular imaging technology and represents the first of a series of related innovations that we expect to launch in the next 18 months," said Isaac Zacharias, vice president and general manager, Imaging, Boston Scientific. "An increase in complex PCIs, coupled with a growing focus on data-driven improvements in outcomes, show that IVUS technology should play a more important role."

To learn more about the OptiCross Coronary Imaging Catheter, visit

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit and connect on Twitter and Facebook.

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, the market for IVUS devices, our business plans, regulatory approvals, clinical trials, as well as product performance and effects. 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 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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