Initial image analysis is conducted by trained technicians/sonographers and reviewed side-by-side with an experienced cardiologist. Every study analyzed in the Core Lab is reviewed by a board certified cardiologist. We believe that this is necessary to maintain quality and it provides the highest level of acceptability by regulatory agencies.
Image analysis is customized based on the protocol and the needs of the sponsor. The physicians and staff in the Core Labs are available to aid in identification of appropriate image analyses to support each study. Analyses include 2-D and volumetric analysis, assessment of anatomy and physiology, assessment of function of the heart and/or implanted device. Given the very diverse nature of cardiovascular disease and the multitude of anatomic and physiologic parameters that can be measured with ultrasound, it is impractical to list all the possible parameters that could be measured. The scope of analysis will be determined after review of the clinical protocol and in collaboration with the sponsor.
The Core Lab analyzes all studies using commercially available, 510K approved workstations. Cardiac ultrasound studies are analyzed on the Phillips Enconcert System and the Digisonics Digiview Review System, and IVUS studies are analyzed using the Indec system. Both echo and IVUS studies can be analyzed in NTSC, PAL or SECAM format (video) or in digital (DICOM) format using all types of media (CD, DVD or MO disk). All equipment is appropriately inventoried and maintained with monthly checks and logs to assure proper function. The Core Lab utilizes commercially available, 510K standard approved workstations for all image analysis.