Healthcare Industry News: Costar stent
News Release - September 5, 2006
Conor Medsystems Announces Two-Year Follow-Up Data from EuroSTAR Pivotal StudyResults Demonstrate Long-term Safety and Efficacy of the CoStar(R) Cobalt Chromium Paclitaxel-Eluting Coronary Stent
MENLO PARK, Calif., Sept. 5 (HSMN NewsFeed) -- Conor Medsystems, Inc. (Nasdaq: CONR ), a developer of innovative, controlled vascular drug delivery technologies, today announced two-year follow-up clinical data from the first arm of its pivotal EuroSTAR study single- and multi-vessel coronary artery disease. The clinical results are being presented today by Keith D. Dawkins, M.D., FRCP, FACC, Director of Cardiac Interventions at Southampton University Hospital, Southampton, United Kingdom, at the European Society of Cardiology/World Congress of Cardiology 2006 in Barcelona, Spain.
"There were low rates of clinical events through 24 months, demonstrating the stability of outcomes with the Costar stent," said Dr. Dawkins. "With its low profile and high radiopacity, the Costar stent is highly deliverable. In addition, the use of bioresorbable polymers ensures that no permanent polymer residue or drug remains at the target site, which may confer a long-term advantage with respect to reduced rates of late stent thrombosis."
A total of 176 lesions were treated in 145 patients using the Costar stent formulated to release a therapeutic dose of 10mcg of paclitaxel per 17mm stent over approximately 30 days (based on in vitro measurements). At 24-month follow-up, the target lesion revascularization rate was 3.6 percent, compared to 2.8 percent at 12-month follow-up, and the cumulative major adverse cardiac event rate was 10.4 percent, compared to 8.3 percent at 12-month follow-up. There were no reported cases of stent thrombosis between the cessation of anti-platelet therapy at six months and 24-month follow-up.
"We are very pleased with the consistent clinical results for the Costar stent, which after two years continues to demonstrate a positive safety and efficacy profile," said Azin Parhizgar, Ph.D., Chief Operating Officer of Conor. "A low-dose, long-release formulation of paclitaxel from a bioresorbable polymer proved to be efficacious over the long-term. The rate of adverse clinical events from six months to 24 months was very low in this population of patients with chronic ischemic heart disease."
In contrast to conventional surface-coated stents, Conor's stents have been specifically designed for vascular drug delivery. Conor's Costar stent incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. In addition, the Costar stent uses bioresorbable polymers that are absorbed by the body after the drug is released, leaving no permanent residual polymers at the target site.
The Costar stent is not available for sale in the United States where it is an investigational device limited by law to investigational use.
About Conor Medsystems
Conor Medsystems, Inc. develops innovative controlled vascular drug delivery technologies, and has primarily focused on the development of drug eluting stents to treat coronary artery disease. For further information on Conor Medsystems and controlled vascular delivery, visit www.conormed.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to clinical development of the Costar stent. All forward-looking statements and other information included in this press release are based on information available to Conor Medsystems as of the date hereof, and the company assumes no obligation to update any such forward-looking statements or information. The company's actual results could differ materially from those described in the company's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under "Item 1A. Risk Factors" in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, filed with the SEC on August 9, 2006, including (i) risks related to the uncertain, lengthy and expensive clinical development process, including, among other things, (a) the risk that clinical results reported to date may not be indicative of future clinical results and that the results the company obtains with its Costar stent in the company's U.S. pivotal clinical trial may not show similar effectiveness, and (b) the risk that the company's stents may not demonstrate a long-term advantage with respect to reduced rates of late stent thrombosis; and (ii) risks related to patent infringement, including, among other things, (a) the risk that if any patent infringement claims or other intellectual property claims against the company are successful, the company may, among other things (1) be enjoined from, or required to cease, the development, manufacture, use and sale of products that infringe the patent rights of others, (2) be required to expend significant resources to redesign its technology so that it does not infringe others' patent rights, or to develop or acquire non-infringing intellectual property, which may not be possible, and/or (3) be required to obtain licenses to the infringed intellectual property, which may not be available to the company on acceptable terms, or at all, and (b) the risk that intellectual property litigation against the company could significantly disrupt the company's development and commercialization efforts, divert management's attention and quickly consume the company's financial resources. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the company's periodic reports filed with the SEC, including the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, filed with the SEC on August 9, 2006.
Source: Conor Medsystems
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