IDE Pivotal Transcatheter Valve Trial

Challenge

A pivotal IDE trial of a transcatheter valve replacement system placed extraordinary demands on imaging. Precise anatomical sizing before the procedure was essential to device selection and patient safety, while consistent core lab review of post-implant imaging over extended follow-up was required to document device performance, positioning, and durability. Measurements taken at different timepoints and by different readers had to remain directly comparable, and every assessment needed to satisfy the evidentiary standard of a PMA submission.

Our Solution

Intrinsic Imaging assembled a dedicated team of cardiovascular radiologists and imaging engineers to evaluate each case. Pre-procedural CT studies were analyzed using three-dimensional multiplanar reconstruction with calibrated measurement methods, yielding reproducible anatomical sizing for every implant candidate. Post-implant assessments followed the same calibrated methodology across all follow-up timepoints, with rigorous quality control applied to every submission so that longitudinal comparisons rested on a consistent measurement foundation.

Results

• 100% technical protocol compliance across implant sites
• Core lab data included in the PMA submission
• Core laboratory assessments accepted by FDA reviewers