>> Conor Medsystems Receives Conditional IDE Approval From the FDA to Begin COSTAR II Pivotal Clinical Trial
- CE Mark Application Filed in Europe
MENLO PARK, Calif., March 23 /PRNewswire-FirstCall/ -- Conor Medsystems, Inc. (Nasdaq: CONR ) today announced that the company has received conditional approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin its COSTAR II pivotal clinical trial. The company expects the data from this trial to support U.S. regulatory approval of Conor's CoStar(TM) cobalt chromium paclitaxel eluting stent for the treatment of restenosis. The COSTAR II pivotal trial (CObalt chromium STent with Antiproliferative for Restentosis) is designed to enroll approximately 1,700 patients at up to seventy U.S. sites and fifteen international sites. The FDA's conditional approval of the IDE requires Conor to provide additional information to the FDA. The study is expected to begin by mid-year, and enrollment is estimated to take six to nine months to complete.
"We are very pleased to achieve this significant milestone, and we look forward to commencing our pivotal U.S. study," said Azin Parhizgar, PhD, Chief Operating Officer of Conor. "To date, we have obtained positive safety and efficacy data on our CoStar stent -- most recently from the six-month follow-up data from our EuroSTAR trial. We believe these results are due to our stent's unique drug reservoir design, which allows for greater control over the direction, rate and duration of drug release. In the U.S. trial we will use the low dose of 10 mcg of paclitaxel per 17 mm stent with a bioresorbable polymer. This system is designed to completely release the drug without any permanent residual polymers remaining at the target site."
The COSTAR II trial will be a randomized, single-blind, non-inferiority study comparing Conor's CoStar stent with Boston Scientific's TAXUS® Express2(TM) drug-eluting stent in the treatment of de novo lesions in patients with single or multi-vessel coronary artery disease. Patients will be asymmetrically randomized between CoStar and the control stent with clinical follow-up at thirty days and eight months. In addition, a 350 patient subset will undergo follow-up angiography at nine months.
The primary endpoint for the study will be major adverse cardiac events (MACE) at eight months, defined as a composite of target vessel revascularization (TVR), myocardial infarction and cardiac-related death. Other endpoints include target lesion revascularization (TLR), binary restenosis, and in-segment and in-stent late loss as measured by angiography. The trial will include a registry for direct stenting. Principal investigators involved in the study include Dean Kereiakes, MD, FACC of the Ohio Heart Health Center in Cincinnati, Ohio, Mitchell Krucoff, MD, FACC of Duke University Medical Center, Durham, North Carolina and Patrick Serruys, MD, PhD of the Thoraxcenter-Erasmus University in Rotterdam, The Netherlands.
Earlier this month Conor reported positive six-month follow-up data from the first arm of the company's EuroSTAR study evaluating the CoStar stent. A total of 176 lesions were treated in 145 patients using the CoStar stent formulated to deliver a dose of 10 mcg of paclitaxel (per 17 millimeter stent) over approximately 30 days (based on in vitro measurements). 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. The TLR rate was 1.7 percent and the MACE rate was 4.8 percent.
CE Mark Application
Data from the EuroSTAR trial was used to support the company's CE Mark application filed earlier this quarter for regulatory approval of its CoStar stent in the European Community. The company anticipates receiving regulatory approval for its CoStar stent in Europe in the second half of 2005. A limited market release of the CoStar stent began this month in India with the company's South Asian distribution partner, Interventional Technologies, Pvt, Ltd. <<
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