BACKGROUND Company: Large medical device company Indication: Thoracic and abdominal aortic aneurysm repair or replacement Phase: Investigational Device Exemption (IDE) pivotal study CHALLENGE The sponsor struggled to generate objective, quantitative efficacy endpoint imaging data with the imaging CROs and core labs they were previously working with because of the complexity, time and cost associated with the required observations and measurements defined in their image evaluation protocol (IEP). This was mostly due to other core labs and imaging CROs attempting to make unique 3-dimensional (3D) measurements using traditional, dated 2-dimensional (2D) image processing and analysis methods and tools. The sponsor engaged ERT to implement technology- enabled image processing and analysis

Join for free to read