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.
Source: Bioretec
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.
Source: Bioretec
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.