Implantation of first patient in Germany
Pixium Vision announces the successful first implantation of a patient in Germany in the PRIMAvera pivotal trial.
- Successful first implantation of a patient in the PRIMAvera study in Germany
- PRIMAvera clinical sites opening in five locations in Germany
- Additional clinical sites to open in additional European countries
This follows approval of the PRIMAvera study by Germany’s Federal Institute for Drugs and Medical Devices, which aims to confirm the safety and the benefits provided by the Prima System and is the last clinical step before seeking market approval in Europe. PRIMAvera clinical sites have now opened in Bonn, Sulzbach, Hamburg, Munich and Ludwigshafen with one more in Tuebingen to follow. The PRIMAvera study was initiated in Q4 2020 and the first patient was implanted in March 2021.
