Swedish designer and manufacturer of implants and technology for bone regeneration, OssDsign, has received CE mark approval for its bio-ceramic burr hole plug, Cranioplug.
The product Cranioplug will complement OssDsign’s lead products Sculpter Cranial and Sculpter Facial, which are available in Germany, the UK, and the Nordic countries, with further market expansion ongoing.
”This is an important step in our continuing efforts to lead the transformation of the cranioplasty market away from bone repair, and into bone regeneration”, says Anders Lundqvist, CEO of OssDsign. ”This device is the result of a patient oriented design approach combined with our proven bio-ceramic material. It will satisfy surgeons needs by filling a gap in the market, while also being a perfect strategic fit with our existing product offering.”
Cranioplug is intended to be used to cover and plug holes drilled into the skull during neurosurgical procedures and to reattach a temporarily removed bone flap. Traditional devices used to reattach bone flaps leave the burr holes exposed, which can have negative aesthetic outcome and contribute to patient dissatisfaction and the need for further surgical procedures.
The proprietary bio-ceramic material used in all OssDsign devices integrates with surrounding native bone and has shown osteoinductive properties, as well as excellent soft tissue compatibility. Ongoing clinical trials aim to further prove the clinical advantage, patient benefits and health economic value of these characteristics. Cranioplug will be launched in selected European markets during 2016.