Boston Scientific Receives CE Mark For Ranger(TM) Drug-Coated Balloon
Innovative Technology Strengthens Company’s Leading Portfolio of Solutions for Peripheral Vascular Disease
MARLBOROUGH, Mass., July 14, 2014 /PRNewswire/ — Demonstrating its continued leadership in the development of innovative solutions for peripheral vascular disease, Boston Scientific Corporation (NYSE: BSX) has received CE Mark for the Ranger(TM) Paclitaxel-Coated PTA Balloon Catheter. The technology is now in full European market launch. The Ranger Drug-Coated Balloon (DCB) provides physicians with an additional option to treat peripheral artery disease, delivering an anti-stenotic drug to diseased vascular tissue while leaving no permanent implant behind.
“The Ranger Drug-Coated Balloon offers tremendous promise and will provide another important tool to treat both above-the-knee and below-the-knee lesions,” said Dierk Scheinert, M.D., director, Center of Vascular Medicine, Angiology and Vascular Surgery at Park Krankenhaus, Leipzig, Germany. “When using contemporary technologies, a significant amount of drug coating can be lost during the handling, insertion and delivery of the device. I am excited by the technology in the Ranger Drug-Coated Balloon, which has the potential to reduce drug loss significantly while optimizing both deliverability and the absorption of the drug in the targeted tissue.”
The Ranger DCB combines the deliverability of the market-leading Sterling(TM) balloon platform and the proven drug Paclitaxel with advanced technologies designed to address the delicate and often unstable nature of the coating associated with contemporary drug-coated balloons. The Ranger DCB features proprietary TransPax(TM) coating technology and an innovative loading tool designed to maintain drug-coating integrity and maximize drug-transfer efficiency resulting in consistent and predictable drug delivery.
“Boston Scientific is a leader in the development of drug-eluting technologies, including nearly 20 years of research on the vascular use of Paclitaxel,” said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. “This latest innovation in drug and coating technology is another example of our commitment to advancing the care of patients worldwide. We are pleased to add a state-of-the-art drug-coated balloon to our leading portfolio of peripheral solutions.”
About Peripheral Artery Disease
Peripheral artery disease (PAD) is a circulatory disorder that results from a build-up of plaque in one or more of the arteries, most often in the legs. As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability, with severe cases often leading to amputation of the affected limb. It is estimated that 12-14 percent of the general population is affected by PAD(1).
1) Shammas NW (2007). “Epidemiology, classification, and modifiable risk factors of peripheral arterial disease.”
Vasc Health Risk Manag 3 (2): 229-34. doi:10.2147/vhrm.2007.3.2.229. PMC 1994028. PMID 17580733
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 www.bostonscientific.com and connect on Twitter and Facebook.
The Ranger DCB is not available for sale in the U.S.
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 markets for our products, our business plans, new product launches and launch cadence, product performance and impact, 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; 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.
Media: Ryan Davenport
Global Media Relations
Boston Scientific Corporation
Investors: Susie Lisa, CFA
Boston Scientific Corporation
SOURCE Boston Scientific Corporation