Bioretec has developed and commercialized what the company reports is the world’s first bioresorbable elastic intramedullary nail, Activa IM-Nail™, which makes implant removal operations redundant. Activa IM-Nail received approval under the CE Mark in 2020.
Interim results of an international postmarket clinical follow-up study show that with the use of Activa IM-Nail in pediatric forearm fractures, post-operative complications and refracture rate were equal to the standard titanium procedure but with a benefit of avoiding secondary implant removal operation.
Activa IM-Nail is made of self-reinforced PLGA with an osteoconductive tricalcium-phosphate marker in the tip, allowing faster mini-invasive navigation with enhanced implant visibility in the x-ray. Shorter versions of the device are suitable for intramedullary distal radius and ulna fracture fixations.
The study assesses the safety and effectiveness of Activa IM-Nails as part of the surgical treatment of dislocated forearm fractures in children between three and 13 years of age. A prospective multicenter study is ongoing in many European countries to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail for patients, their parents and other caregivers. To date, the study has assessed interim results on 76 patients.
Bioretec has developed and commercialized what the company reports is the world's first bioresorbable elastic intramedullary nail, Activa IM-Nail™, which makes implant removal operations redundant. Activa IM-Nail received approval under the CE Mark in 2020.
Interim results of an international postmarket clinical follow-up study show that...
Bioretec has developed and commercialized what the company reports is the world’s first bioresorbable elastic intramedullary nail, Activa IM-Nail™, which makes implant removal operations redundant. Activa IM-Nail received approval under the CE Mark in 2020.
Interim results of an international postmarket clinical follow-up study show that with the use of Activa IM-Nail in pediatric forearm fractures, post-operative complications and refracture rate were equal to the standard titanium procedure but with a benefit of avoiding secondary implant removal operation.
Activa IM-Nail is made of self-reinforced PLGA with an osteoconductive tricalcium-phosphate marker in the tip, allowing faster mini-invasive navigation with enhanced implant visibility in the x-ray. Shorter versions of the device are suitable for intramedullary distal radius and ulna fracture fixations.
The study assesses the safety and effectiveness of Activa IM-Nails as part of the surgical treatment of dislocated forearm fractures in children between three and 13 years of age. A prospective multicenter study is ongoing in many European countries to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail for patients, their parents and other caregivers. To date, the study has assessed interim results on 76 patients.
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