Bioretec’s ActivaPin™ bioresorbable implant provides good alternative treatment of pediatric elbow injuries
Bioretec Ltd Press release 23 August 2022 at 9 a.m. EEST
A recently published clinical study confirms the benefits of using fully bioresorbable ActivaPin™ implant together with bioabsorbable suture, for the tension band wire treatment of pediatric medial epicondyle humeral fractures. A tension band wire is a form of orthopaedic internal fixation method used to convert distraction forces into compression forces, promoting bone healing. The results of the retrospective cohort study shows that patients treated with bioresorbable ActivaPin™ were provided a good alternative treatment against traditional non-biodegradable metallic implants but without a need for second surgical intervention (i.e. metal implant removal).
Medial humeral epicondyle fractures account for 10% to 20% of elbow injuries in children. According to the study, the safety and efficiency of bioabsorbable implant is comparable to other novel approaches and traditional metallic implants. However, the non-biodegradable metal implants often require removal surgery that can cause even further complications. The ActivaPin™ implant is made of self-reinforced bioresorbable polymer (PLGA), which safely disappears in the body in approximately two years.
In the study, a total of 24 consecutive patients were retrospectively reviewed between January 2016 and January 2019. The patients underwent operations due to medial humeral epicondyle fractures and were treated with bioresorbable ActivaPin™ along with tension band polydioxanone sutures. Postoperatively, the clinical outcome was confirmed in different follow up time points with X-rays . At 4 weeks, all patients showed callus formation on the X-ray. By the third postoperative month, the range of motion of the elbow was complete in 22 patients, and the other 2 children regained their full range of movement by the sixth month. No growth disturbance, necrosis, or axial malalignment were observed during the follow-up period of 16 – 60 months, neither any nonunion nor delayed union.
“One of the corner stones of Bioretec’s strategy is to provide strong clinical evidence of the company’s bioresorbable products. Again, we are able to present a safe and efficient surgical technique using fully bioresorbable products for the benefit of the patients. The traditional surgical method with non-bioresorbable products for the treatment of pediatric humeral epicondyle fractures leads to removal operations. According to the authors, many surgeons routinely remove implants from children because they do not want to leave them in the growing bone, and general anesthesia associated with secondary surgery may be a source of additional potential complications. Once more, as secondary operation is not needed with our products, 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 (Kassai, Tamás MD; Varga, Marcell MD, PhD; Józsa, Gergö MD, PhD (2022)) were published in Medicine, a well-known peer reviewed scientific journal. The results can be read in full at http://dx.doi.org/10.1097/MD.0000000000029817
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.