Integrum’s OPRA™ Implant System gets FDA approval for clinical study on below-knee amputations
Mölndal, Sweden – October 30, 2023 — Integrum (publ) (Nasdaq First North Growth Market: INTEG B) today announces that the company’s OPRA™ Implant system is approved by FDA to be used in a clinical study on below-knee amputations in the US
The clinical study will be important for the future approval of the OPRA™ Implant System on the below-knee amputation level, which is the most frequent amputation level. The study will be performed by the Walter Reed National Military Medical Center.
“This is an important milestone in the expansion of indications for our OPRA™ Implant System.” said Rickard Brånemark, CEO of Integrum.