Major Aortopulmonary Collateral Arteries (MAPCA) clinical trial under IRB approval. True 3D Viewer 1.0 is 510K cleared by FDA; development and 510K clearance in process for all other applications

Luminary Site: Stanford University Medical Center

Principal Investigator: Frandics Chan, MD. Associate Professor of Radiology (General Radiology) at the Stanford University Medical Center. 

The Problem: 

Children born with pulmonary atresia (PA) with major aortopulmonary collateral arteries (MAPCA) must undergo a surgery that requires precise mapping of all native vessels supplying the lungs. As each patient has his unique vascular anatomy, visual comprehension can be extremely challenging. Doctors must integrate a series of 2D images in their mind to reconstruct the relevant 3D anatomy and, often, clinically significant information is lost

Case Studies:

 In a published article, physicians using CA and CTA images of newborns diagnosed with PA and MAPCA, a cardiologist evaluated and compared traditional tomographic readouts with those performed using EchoPixel’s True 3D. Their sample consisted of 774 vessel branches that surgeons evaluated to plan and perform the reconstructive surgery. The researchers found that the information provided to the cardiologist by the True 3D Viewer both improved the physician’s ability to detect structural details and anatomical relationships resulting in shorter interpretation time. The physician’s sensitivity with standard 2D tomographic reading was 81% compared with 90% when using the True 3D System. The average time for physicians to perform their interpretations with tomographic readout was 22 ± 7 minutes compared to only 13 ± 4 minutes when using the information provided by True 3D.