CUSTOM Pk

Our CUSTOM Pk clinical trial was designed to evaluate the safety and pharmacokinetic profile of the Custom NX^® DES System when implanted in patients with de novo lesions in native coronary arteries. Enrollment of 28 patients was completed in January of 2008 at two cardiology centers in Europe. Blood samples were drawn at 15 time points to determine the pharmacokinetics of Biolimus A9, and clinical and safety assessments were performed at six of these 15 time points.