Healthcare Industry News: Self-Expanding Nitinol Stent
News Release - July 18, 2007
Angiotech's corporate partner, Cook Medical, announces enrollment in pivotal study of paclitaxel-coated stent for use outside the heartVANCOUVER, July 18 (HSMN NewsFeed) - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, along with its corporate partner, Cook Medical Inc., announced that the first U.S. patients in the pivotal approval trial of a potentially revolutionary new type of drug-eluting stent designed to prevent blockages in arteries outside the heart were treated at Tri-City Medical Center in Oceanside, California. The patients were treated by principal investigator Dr. Richard Saxon, assistant clinical professor of radiology at University of California, San Diego, as part of the international Zilver PTX Stent Trial.
The pivotal trial is intended to evaluate paclitaxel-eluting stents in treating peripheral arterial disease (PAD), a serious medical condition that affects more than 10 million Americans each year. The study will determine if the same type of drug-eluting technology found in popular drug-coated stents used to treat blockages in the coronary arteries can be used to treat blockages in arteries outside the heart. Following successful safety testing during the trial's Phase I enrollment, Cook will enroll over 700 patients in the pivotal trial that will be used to support submission to the U.S. Food and Drug Administration for approval to market the device.
The Zilver PTX Stent Trial is being conducted at 28 U.S. locations and is the first medical device trial ever conducted simultaneously in the U.S. and Japan. Clinical data collected on Japanese and U.S. patients will be combined for the final evaluation of the device and used for regulatory submissions in both markets for approval. The trial will enroll patients who will be randomized to receive either the Zilver PTX stent or balloon angioplasty.
About Zilver PTX
Cook Medical's Zilver PTX, a Self-Expanding Nitinol Stent, uses a proprietary, polymer-free technology to coat the device with paclitaxel, an antiproliferative drug that has been used successfully to reduce the risk of renarrowing of arteries following angioplasty. In many cases, PAD patients who have been treated with balloon angioplasty and stenting experience restenosis, or renarrowing of the arteries, over time and must undergo more invasive treatment such as bypass surgery to reopen the arteries. The Zilver PTX trial will determine whether the combination of the stent and paclitaxel will keep arteries open over time.
About Peripheral Artery Disease (PAD)
Peripheral Artery Disease (PAD) affects blood vessels that lead from the heart to other areas of the body, such as the legs, feet and kidneys. When the blood vessels become blocked due to the build-up of fatty deposits, blood circulation is restricted. Untreated, PAD results in pain when walking and can lead to gangrene and amputation.
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.
Cook Medical is a co-exclusive licensee to Angiotech's proprietary paclitaxel technology for use in certain peripheral vascular and non-vascular fields of use.
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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