Promus PREMIER™ Everolimus-Eluting Platinum Chromium Stent System Receives CE Mark Approval
NATICK, Mass., Feb. 12, 2013 -- Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's next-generation durable polymer drug-eluting stent (DES) technology, and is starting its European market launch. The Promus PREMIER Stent System is designed to provide physicians improved DES performance in treating patients with coronary artery disease. It is the only platform to feature a customized Platinum Chromium (PtCr) stent architecture, the market-leading Everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery system. Images of the Promus PREMIER Stent System are available for download here.
Coronary heart disease is a narrowing of the vessels that supply blood and oxygen to the heart. Recent statistics from the European Heart Network and the European Society of Cardiology show it is the single most common cause of death in Europe accounting for 1.8 million deaths in Europe per year. Patients living with coronary heart disease, also known as coronary artery disease, may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack. One treatment option is the placement of a stent in the artery to help keep it open and allow the blood to flow more freely.
"The customized Platinum Chromium stent architecture maintains the superior visibility, exceptional radial strength and fracture resistance, minimal recoil and outstanding clinical outcomes of a PtCr Everolimus-Eluting stent while offering improved longitudinal strength," said John Ormiston , M.D., Mercy Angiography, Auckland City, New Zealand. "In addition, the enhanced stent delivery system offers improved deliverability. Stent design is a balance of trade-offs and the Promus PREMIER Stent System appears to have it right."
The Promus PREMIER Stent System was developed with input from physicians. The customized Platinum Chromium alloy stent architecture provides strength without compromising flexibility. An enhanced low-profile delivery system features a shorter, more visible tip, dual-layer balloon and Bi-Segment™ inner lumen catheter designed to facilitate precise stent delivery across challenging lesions. The Everolimus drug and fluorinated co-polymer stent coating have been studied in multiple randomized clinical trials demonstrating long-term safety and efficacy. The PLATINUM Workhorse Trial compared the PROMUS Element™ Stent (Platinum Chromium Everolimus-Eluting stent) to the Xience V™ Stent (Cobalt Chromium Everolimus-Eluting stent), and demonstrated that Platinum Chromium technology has superior clinical outcomes between years one and two.
"The Promus PREMIER Stent System is the latest example of our unparalleled pipeline of drug-eluting stent technologies and reflects our commitment to global DES market leadership," said Kevin Ballinger , president, Interventional Cardiology, Boston Scientific. "We are proud that our research, clinical, regulatory and manufacturing teams delivered the next advance in stent technology in an expedited time. In partnership with physicians, we expect to continue to innovate and build on our industry-leading Platinum Chromium platform."
The Promus PREMIER Stent System is currently offered in a matrix of 47 sizes, ranging in diameter from 2.25 mm to 4.00 mm and lengths of 8 mm to 38 mm on a Monorail® catheter platform. This comprehensive offering provides cardiologists and their patients a broad range of options designed to best suit their needs. The Promus PREMIER Stent System is not available for sale in the United States or Japan.
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 us at 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 our business plans, technology and product pipeline, markets for our products and our position in those markets, new product launches and launch cadence, product performance 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.