Case Study: REVA Medical achieves CE mark for Fantom device with ClinCapture

Reva - Customer Case Study

Reva, a medical device company developing the Fantom drug‑eluting bioresorbable coronary scaffold, needed robust clinical-trial evidence to secure regulatory approval. To run its pivotal study, Reva used ClinCapture’s electronic data capture/data management platform to collect and manage trial data.

ClinCapture provided the EDC solution that supported compliant, high-quality data collection and analysis for Reva’s trial; using data from the study performed on ClinCapture, Reva received a CE mark for the Fantom device — a clear regulatory milestone enabling market access for the scaffold.

Reva