US health care major Abbott Laboratories says that the first patients have been enrolled in its European clinical trial of its ZoMaxx drug-eluting coronary stent system for their coronary artery disease.
The single-arm study will evaluate the safety and performance of ZoMaxx which is designed to elute Abbott's patented immunosuppressant drug, zotarolimus, in patients with single- or two-vessel coronary artery disease, representing an important step toward broadening the complexity of conditions treated with this device.
The evaluation will include approximately 900 patients at up to 60 sites throughout Europe with a primary endpoint of target lesion revascularization at nine months. Illinois-headquartered Abbott plans to file Zomaxx for marketing authorization during the year.
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