Bonesupport wins FDA nod for Cerament G trial

Bonesupport said it won an investigational device exemption for the Fortify clinical trial of its next-generation Cerament G injectable antibiotic-eluting bone substitute. Cerament G product is an osteoconductive, ceramic substance designed to promote bone healing while preventing bone infection, or osteomyelitis. The resorbable bone graft substitute is designed to remodel into healthy bone within 6-12 months, while preventing colonization of microorganisms by eluting the antibiotic gentamicin. Bonesupport said Cerament G, which won CE Mark approval in the European Union back in February 2013, is on the market in 19 countries. The 230-patient Fortify study is designed to evaluate the safety and efficacy of Cerament G in surgical repair of open diaphyseal tibial fractures, Lund, Sweden-based Bonesupport said, noting that it hopes to enroll 50% of the trial’s subjects in the U.S. Enrollment is expected to begin by the end of the year, the company said. Other study endpoints include the absence of deep infection at the fracture site and absence of surgical or nonsurgical secondary procedures to promote fracture union, Bonesupport said. “The FDA approval of our planned IDE study with Cerament G is a key corporate milestone for Bonesupport. We are looking forward to beginning the Fortify study before the end of 2016. The results of this study will form a key component of our planned PMA to gain US approval for this novel antibiotic-eluting bone graft substitute...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Source Type: news