Healthcare Industry News: drug-eluting stent
News Release - July 18, 2007
Angiotech's corporate partner, Boston Scientific, announces first human use of TAXUS(R) Petal(TM) Bifurcation StentVANCOUVER, July 18 (HSMN NewsFeed) - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, along with its corporate partner Boston Scientific Corporation "BSC" (NYSE: BSX ), announced the successful implantation of BSC's TAXUS® Petal(TM) Bifurcation Paclitaxel-Eluting Stent System (TAXUS Petal Stent) in a patient in New Zealand, marking the beginning of the TAXUS PETAL I First Human Use (FHU) Trial.
The trial is designed to evaluate the safety of a dedicated bifurcation paclitaxel-eluting stent platform for the treatment of coronary artery disease. The procedure was performed by John Ormiston, M.D., at Auckland City Hospital in Auckland, New Zealand.
A significant percentage of coronary artery disease - as much as 30 percent - occurs at a bifurcation, where one artery branches into two smaller arteries (one being the continuation of the main branch and the other often referred to as the side branch). Bifurcations present a common location for the build-up of plaque and are particularly difficult to treat with currently available stents. Conventional coronary stents were designed to treat tubular arteries and are considered less than optimal for the y-shaped anatomy of a bifurcation. The TAXUS Petal Stent is designed specifically to treat both the main branch and the side branch of a bifurcation.
The TAXUS Petal Stent consists of a traditional drug-eluting stent with an innovative side structure (the Petal Strut) in the middle of the stent that opens into the side branch. The TAXUS Petal is designed to provide access, coverage and support to the critical areas of the bifurcation and uses a proprietary platinum chromium alloy. Platinum chromium is designed to offer an improvement over stainless steel and cobalt chromium, enabling even thinner struts, increased flexibility and improved radiopacity. The TAXUS Petal Stent is coated with the proven, market-leading combination of the Paclitaxel drug and Translute(TM) polymer.
"The TAXUS Petal Stent enabled us to successfully treat a patient with a difficult bifurcation (coronary branch point) stenosis. Bifurcations are a major challenge in interventional cardiology, and the development of a dedicated drug-eluting bifurcation stent is an important advancement," said Dr. Ormiston, the principal investigator for the TAXUS Petal I FHU Trial. "A major strength of the TAXUS Petal Stent design is to provide consistent mechanical support and drug application not only to the main branch but also to the side-branch ostium, where renarrowing is common with other techniques used today."
The TAXUS PETAL I FHU clinical trial is a non-randomized study with an initial assessment of acute performance and safety (death, myocardial infarction, target vessel revascularization) at 30 days and six months, as well as continued annual follow-up for five years. TAXUS PETAL I FHU will enroll a total of 45 patients in New Zealand, France and Germany. Upon successful completion of this study, BSC intends to begin a pivotal trial to gain U.S. and international approval for the commercialization of the TAXUS Petal Stent.
"We are excited by the start of the TAXUS PETAL I FHU Trial and the fact that our paclitaxel technology may offer a solution to bifurcations, which is an area in coronary stenting that remains challenging for physicians," said Dr. William Hunter, President and CEO of Angiotech.
The TAXUS Petal Stent is under development and not available for sale.
Note on Forward Looking Statements
Statements contained in this press release that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects" and similar expressions, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and constitute "forward-looking information" within the meaning of applicable Canadian securities laws. All such statements are made pursuant to the "safe harbor" provisions of applicable securities legislation. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following; general economic and business conditions, both nationally and in the regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products and decisions regarding reimbursement where applicable; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and any other factors that may affect performance. In addition, our business is subject to certain operating risks that may cause the actual results expressed or implied by the forward-looking statements in this report to differ materially from our actual results. These operating risks include; poor performance of the product in the clinical setting; adverse events related to the use of the product; improper estimation of the size of the product markets; adverse results or unexpected delays in clinical development processes; our ability to attract and retain qualified personnel; our ability to successfully complete preclinical and clinical development of our products; changes in business strategy or development plans; our failure to obtain patent protection for discoveries; loss of patent protection resulting from third party challenges to our patents; commercialization limitations imposed by patents owned or controlled by third parties; our ability to obtain rights to technology from licensors; liability for patent claims and other claims asserted against us; our ability to obtain and enforce timely patent and other intellectual property protection for our technology and products; the ability to enter into, and to maintain, corporate alliances relating to the development and commercialization of our technology and products; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the continued availability of capital to finance our activities; our ability to continue to integrate into our business the operations of American Medical Instruments Holdings, Inc. and our ability to achieve the operational and other synergies and the other commercial or financial benefits expected as a result of that acquisition; and any other factors referenced in our annual information form and other filings with the applicable Canadian securities regulatory authorities or the SEC.
Given these uncertainties, assumptions and risk factors, readers are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained in this prospectus to reflect future results, events or developments.
BSC acquired worldwide exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and has co-exclusive rights to certain peripheral vascular and non-vascular products.
®, (TM) Trademarks of Boston Scientific Corporation
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech (NASDAQ: ANPI, TSX: ANP), please visit our website at www.angiotech.com.
Source: Angiotech Pharmaceuticals
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