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  • gbdido gbdido Mar 9, 2005 8:12 AM Flag

    Zero % Restenosis (part 1)

    Conor Medsystems Presents Positive 12-Month Results from PISCES First- Generation Paclitaxel Drug-Eluting Stent Trial at American College of Cardiology Scientific Session

    Tuesday March 8, 10:45 am ET

    - Results Reinforce Safety, Optimal Dose and Kinetic Release Characteristics of Innovative Stainless Steel Paclitaxel Drug Delivery Stent Technology

    MENLO PARK, Calif., March 8 /PRNewswire-FirstCall/ -- Conor Medsystems, Inc. (Nasdaq: CONR - News) today presented twelve-month follow-up data from its PISCES (Paclitaxel In-Stent Controlled Elution Study) clinical trial at the American College of Cardiology (ACC) scientific session in Orlando, Florida. The data, presented by Patrick Serruys, M.D., Ph.D., Chief, Interventional Cardiology, Thoraxcenter-Erasmus University in Rotterdam and the study's Principal Investigator, support the long-term safety and efficacy of Conor's novel cardiovascular stent technology. PISCES was designed to study Conor's first-generation stainless steel paclitaxel-eluting stent in the treatment of native coronary artery lesions. In a related announcement earlier this week, Conor also presented positive clinical safety, efficacy and angiographic findings on the company's CoStar(TM) cobalt chromium drug-eluting stent.
    "We are very pleased with PISCES' twelve-month data, which confirms the safety of our proprietary stent technology," said Frank Litvack, M.D., Chairman and CEO of Conor. "Building off the insights we gained from this first-generation technology, we have designed our cobalt chromium CoStar paclitaxel-eluting stent, which has thinner struts and uses significantly less polymer, to provide controlled delivery of therapeutic levels of drug."

    PISCES, a multi-center study involving 191 patients from ten sites across seven countries, was designed to compare the safety and performance of paclitaxel delivered at different rates, directions, and doses using Conor's stainless steel stent. Each patient participating in the PISCES trial received one of six different formulations of paclitaxel to evaluate unique doses, drug release rates (fast, medium and slow) and directionality (drug release to only the arterial wall versus release to both the wall and the lumen).

    At twelve-month follow-up, all six formulations were determined to be safe and efficacious. There were no reported cases of delayed stent thrombosis between six months, when patients ceased antiplatelet therapy, and twelve- month follow-up. In comparison to the other four formulations, the two groups with slow-release formulations (approximately 30 days based on in vitro measurements) had particularly good outcomes.

    The group of patients receiving a 10mcg (per 17mm stent) slow-release formulation had an in-stent binary restenosis rate of 0 percent and a target lesion revascularization (TLR) rate of 0 percent at twelve-month follow-up. The rate of major adverse cardiac events (MACE) was 5.1 percent, not statistically different from the MACE rate at four months. From four-month to twelve-month follow-up, in-stent late loss increased to 0.52mm from 0.40mm, and in-segment late loss increased to 0.30mm from 0.21mm.

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