FDA OKs trial for Raymedica's next-generation spinal technology
This article was originally published in Clinica
Executive Summary
Raymedica has received US FDA approval to enrol patients in a US clinical study for its next-generation nucleus replacement device for treating pain caused by degenerative disc disease (DDD). The "HydraFlex" device will better fit and fill the nucleus space than its previous model, claimed the firm. There are currently no disc nucleus replacements approved in the US, though several such products are CE-marked for sale in Europe, including devices from Raymedica.