This approval allows Evera Medical to assess the safety and effectiveness of the FulFil Lip implant in patients undergoing aesthetic lip enhancement. Enrollment into the study, named EIFFEL (Evera Implant – FulFil – For Enhancement of the Lip), is expected to begin within 30 days.
Michael Lesh, CEO of Evera Medical, said: “In formulating EIFFEL, we worked closely with the FDA, who reviewed our extensive bench and biocompatibility testing along with the long-term outcomes of our international lip augmentation study. We are quite pleased with this approval and are optimistic that the trial endpoints will be met. FulFil Lip will be the first treatment of any kind to be specifically labeled for lip enhancement.”