BONESUPPORT Receives FDA Approval to Initiate IDE Clinical Study
BONESUPPORT received FDA approval to launch an Investigational Device Exemption study of CERAMENT G in the treament of open diaphyseal tibial fractures, slated to start by the end of 2016.
The randomized, multicenter, controlled, 230-patient FORTIFY trial will evaluate safety and efficacy of the injectable gentamicin antibiotic-eluting bone graft substitute as part of surgical repair. BONESUPPORT intends for at least 50% of the study data to come from U.S. subjects.
At the start of 2016, BONESUPPORT announced the milestone of >20,000 patients treated worldwide with CERAMENT products. CERAMENT G received CE Mark approval and launched in the EU in 1Q13, while CERAMENT V (vancomycin-eluting) entered EU launch in early 2Q15.
Sources: BONESUPPORT AB, ORTHOWORLD Inc.