Bioretec's ActivaPin™ bioresorbable implant provided excellent clinical outcome in the treatment of pediatric wrist fractures
HELSINKI, April 25, 2022 /PRNewswire/ -- The published clinical study confirms the significant benefits of Bioretec's bioresorbable ActivaPin™ implants for pediatric patients in the treatment of severely displaced distal radius and forearm fractures. The results of the retrospective multicenter study indicate that patients treated with bioresorbable ActivaPin™ had significantly lower level of complications than those treated with traditional non-biodegradable metallic Kirschner-wires (K-wires) and no second surgical intervention was required.
Distal radius fractures are very common in pediatric patients, and severely displaced fractures may require surgical intervention. The current best practice surgical method is percutaneous K-wire osteosynthesis followed by immobilization. However, the non-biodegradable metal implants often require removal surgery that can cause further complications. The ActivaPin™ implant is made of bioresorbable polymer (PLGA), which safely disappears in the body in approximately two years.
In the study, a total of 94 patients were reviewed in three pediatric trauma centers. The patients underwent operations due to severely displaced distal forearm radial fractures and were treated with either K-wire or with bioresorbable ActivaPin™. The study groups were examined for the number of minor and major complications as well as the need for repeated interventions. The complication rate of the ActivaPin™ group was significantly lower than of K-wire group, and there were no major complications associated with ActivaPin™. In addition, no signs of growth disturbance were found in any of the children after long term 18 months follow-up of the injury.
"The results of the study are very encouraging. The novel surgical technique leads to less complications and also offers major advantages to surgeons. The benefits of ActivaPin™ were most pronounced in the first six weeks after surgery: the number of outpatient visits were reduced, and children's sense of comfort was increased. In addition, avoiding second surgical intervention results in significant cost savings. And most importantly, children can return to their normal everyday life and activities faster," says Timo Lehtonen, CEO of Bioretec, a globally operating Finnish medical device company and a pioneer in bioresorbable orthopedic implants.
The ActivaPin™ has been in the market since 2008, and the product is currently used in over 30 countries.
The results of the study (Varga et al. BMC Musculoskeletal Disorders (2022) 23:362) were published in BMC Musculoskeletal Disorders, a well-known peer reviewed scientific journal. The results can be read in full at https://bit.ly/3rJj5tX.
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
Information about Bioretec
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 intends to introduce a new generation of bioresorbable materials with enhanced strength for improved surgical outcome. The new RemeOs™ product line is based on a magnesium alloy and hybrid composite. 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.
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