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Conor Medsystems Announces Positive Angiographic and Clinical Results for EuroSTAR Drug-Eluting Stent Trial
MENLO PARK, Calif., March 5, 2005 /PRNewswire-FirstCall via COMTEX/ - Conor Medsystems, Inc. (Nasdaq: CONR) today presented angiographic and clinical data from the company's pivotal EuroSTAR study evaluating its CoStar® cobalt chromium paclitaxel-eluting stent in a complex patient cohort. The six-month follow-up data, demonstrating positive angiographic and clinical results for the treatment of single or multiple de novo lesions in native coronary arteries, were presented by one of the study's Principal Investigators, Keith D. Dawkins, MD, FRCP, FACC, Director of Cardiac Interventions at Southampton University Hospital, Southampton, United Kingdom, at the DES Revolution IV, a Cardiovascular Research Foundation-sponsored symposium immediately preceding the American College of Cardiology (ACC) meeting in Orlando, Florida.
A total of 176 lesions were treated in 145 patients using the CoStar stent formulated to release a therapeutic dose of 10mcg of paclitaxel over approximately 30 days (based on in vitro measurements). Complex characteristics of the patient group include diabetes in 16 percent of patients, an average vessel diameter of 2.64 millimeters, and multi-vessel disease in more than 50 percent of patients. Approximately 52 percent of the lesions were treated by direct stenting.
At six-month follow-up, the in-stent binary restenosis rate was 3.4 percent and the in-stent late loss was 0.26 millimeters. The in-segment binary restenosis rate was 4.7 percent and the in-segment late loss was 0.07 millimeters. As previously reported, the target lesion revascularization (TLR) rate was 1.7 percent and the rate of cumulative major adverse cardiac events (MACE) was 4.8 percent.
"We're very pleased to report the encouraging follow-up angiographic results as we continue to demonstrate the safety and clinical benefits of our CoStar cobalt chromium paclitaxel-eluting stent," said Frank Litvack, MD, Chairman and CEO of Conor. "In addition, we have received positive feedback from our investigators on the ease of delivering our cobalt chromium stents in patients with diverse vessel characteristics. The novel design of our non-surface coated stents, with their proprietary ductile hinges and drug reservoirs, allows for enhanced control over the rate and duration of drug delivery, which we believe provides for optimal drug release and sustained stent performance."
"The results of this trial demonstrate consistently low restenosis and complication rates for the CoStar stent across an array of patients," said Dr. Dawkins. "These findings, coupled with the stent's predictable and controlled drug release, bioresorbable polymer and ease of deliverability, highlight the potential of the CoStar stent in providing clear benefits to both patients and physicians."
In contrast to conventional surface-coated stents, Conor's CoStar cobalt chromium paclitaxel-eluting coronary stent has been specifically designed for vascular drug delivery. CoStar's design differs from conventional surface-coated stents as it incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. Conor's stent design enables a wider range of drug therapies -- including combinations of multiple compounds -- and provides greater control over the direction and rate of drug release, which Conor believes allows for more targeted treatment within the artery and more efficient use of the therapeutic agent.
EuroSTAR (EUROpean cobalt chromium STent with Antiproliferative for Restenosis) is a prospective, multi-center, two-arm dose-ranging pivotal study evaluating the safety and performance of Conor's CoStar stent for the treatment of restenosis. The study is scheduled to sequentially enroll patients from 18 European centers into one of two registry arms with two different dose formulations of paclitaxel. The six-month follow-up data reflects the first arm of the study which evaluated the clinical performance of a 10mcg dose formulation (per 17mm stent) released over approximately 30 days. The second arm of the study, which recently completed enrollment, will evaluate a 30 mcg dose released over 30 days.
About Conor Medsystems
Conor Medsystems, Inc. develops innovative controlled vascular drug delivery technologies, and has initially 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.
The CoStar stent is an investigational device and is not available for sale in the United States.
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 product development. 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 the heading "Risk Factors" in the Company's prospectus filed with the SEC on December 14, 2004 pursuant to Rule 424(b), including (i) the risk that if any patent infringement claims or other intellectual property claims against the Company are successful, the Company may, among other things (a) be enjoined from, or required to cease, the development, manufacture, use and sale of products that infringe the patent rights of others, including the Company's CoStar stent, (b) be required to expend significant resources to redesign its technology so that it does not infringe others' patent rights, which may not be possible, and/or (c) be required to obtain licenses to the infringed intellectual property, which may not be available to the Company on acceptable terms, or at all, (ii) 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, and (iii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including, among other things, (a) the risk that clinical results reported to date may not be indicative of future clinical results and that longer-term results the Company obtains with its CoStar stent may not show similar effectiveness, (b) the risk that the third parties on whom the Company relies to conduct its clinical trials may not perform as contractually required or expected, (c) the risk that the Company's clinical trials may not be completed on schedule, or at all, and (d) the risk that the Company may never obtain FDA and equivalent foreign market approvals. 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 prospectus and the Company's future periodic reports to be filed with the SEC.
SOURCE Conor Medsystems, Inc.
