Bioabsorbable antibiotic-releasing screw gets CE Mark
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The Finnish biotechnology company Bioretec Ltd. announced that it has obtained the CE mark and sales permit in European Union (EU) countries for its bioabsorbable antibiotic-releasing screw. The novel implant helps reduce infections and the need for reoperations on patients with bone fractures, according to a company press release.
The antibiotic-releasing CiproScrew implant fixes and supports bone during healing while precisely and safely releasing an antibiotic locally to prevent infections, the company said. It is indicated for complicated fractures, osteotomies, arthrodeses and in the fixation of bone fractures in patients when infection is a potential risk. Advanced age and illnesses such as diabetes, rheumatoid arthritis, osteoporosis and alcoholism increase the risk of infection. Trauma surgery patients are particularly prone to serious infections arising from bone fracture fixation, according to the release.
Professor Hannu T. Aro of Turku University Hospital, who performed ankle fracture fixations using the antibiotic-releasing screw, stated “The new antibiotic-releasing screw works well in the treatment of these difficult injuries, and it is as effective as metal screws. Should the antibiotic-releasing screw prove to be as successful in broader patient studies, future patients will no longer need to take antibiotics prior to their operation.”
Bioretec’s founder, Professor Pertti Törmälä, has 30 years experience researching bioabsorbable materials. He stated in the release, “We have improved our manufacturing processes and machinery over the years. Improvements enable us to successfully combine two different material components. The strength properties of the new antibiotic screw are based on Bioretec`s in-house developed process to create mechanically active polymer-material. Infection prevention is based on the combined broad-spectrum ciprofloxacin. The implant degrades in a controlled manner over the course of two years, releasing the antibiotic for about 6 months after the surgery.”
Bioretec will start CiproScrew deliveries in early of December.