Bioresorbable Activa IM-Nail™ shows convincing results in Post-Market Clinical Follow-up study for the treatment of children’s forearm fractures
Bioretec Ltd HELSINKI: BRETEC Press release 1 June 2022 at 1.00 p.m. EET
Forearm fractures are a common injury in children and adolescents. When operative treatment is needed, intramedullary nailing with elastic titanium nail (ESIN) is the most common surgical procedure. On many occasions, the implant is removed after fracture has healed. Removal is needed to avoid related long-term complications such as irritations, infections or growth disturbance. The interim results of the international Post-Market Clinical Follow-up (PMCF) study show, that the use of Activa IM-Nail™ in pediatric forearm fractures with regard to various study objectives, including the clinical outcome, post-operative complications and refracture rate are equal to the standard titanium procedure but with a benefit of avoiding secondary implant removal operation.
To decrease the burden of the healthcare system and the discomfort of the pediatric patient Bioretec has develop and commercialized the world’s first bioresorbable elastic intramedullary nail Activa IM-Nail™, which makes implant removal operations redundant. Activa IM-Nail™ received market authorization (CE-mark) in Europe in 2020.
The PMCF study assesses the safety and effectiveness of Activa IM-Nails™ as part of the surgical treatment of dislocated forearm fractures in children between 3 and 13 years of age. A prospective multicenter study is on-going 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. At this stage of the study, interim results on 76 patients are analyzed and published1 in high impact rate and distinguished scientific journal: “Children”.
- Roeder, C.; Alves, C.;Balslev-Clausen, A.; Canavese, F.; Gercek, E.; Kassai, T.; Klestil, T.; Klingenberg, L.; Lutz, N.; Varga, M.; et al. Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children. Children 2022, 9, 754.https://doi.org/10.3390/children9050754
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioresorbable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes. The RemeOs™ implants are resorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. With the U.S. and EU market authorization for the first RemeOs™ product expected in 2022, Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical possibilities. Better Healing – Better Life. www.bioretec.com.