Providing solutions by integrating CAD and 3D technologies into medical applications, OssDsign reached the chance to get in USA market thanks to FDA approval.
Benefiting from new generation technologies in cranial and facial implants, Sweden based OssDsign prepares to present its solutions in America. Producing patient specific implants, the firm’s most demanded product OSSDSIGN® Cranial PSI received the approval of FDA (Food and Drug Administration). Thanks to that, OssDsign aims to increase product volume and reliability in the market.
OSSDSIGN Cranial is a patient-specific medical implant intended for reconstruction of cranial defects, a surgical procedure known as cranioplasty. Cranioplasty is traditionally performed by neurosurgeons using the patient’s own bone or by using implants made from inert plastic or metal materials, such as PEEK or titanium. These techniques are known to have a high complication rate, especially infections which may necessitate removal of the implant and further surgery. Every OSSDSIGN Cranial implant is made to each patient’s unique requirements based on the patient’s computer tomography (CT) information. OssDsign uses advanced computer-assisted design (CAD) and state-of-the-art 3D-printing technologies to produce each unique device. The implant is made from a proprietary calcium phosphate composite, which is reinforced by a strong titanium skeleton.
Lars Kihlström, MD, Senior Consultant of Neurosurgery at Karolinska University Hospital, said: “I believe that OSSDSIGN Cranial is a very promising product for cranial bone reconstruction that has led to positive results with two years follow up after introduction. We have used OSSDSIGN Cranial since it was introduced in Sweden; not only does it have good handling characteristics, it also substantially contributes to good outcomes in complex patient groups.”
OSSDSIGN Cranial and other OssDsign products have been introduced step-wised in Europe since 2014. These products are already available in Germany, the UK and Nordic region, as well as Singapore and Israel. Earlier this month OssDsign announced that it had entered into new commercial partnerships to distribute its medical implants in Italy, Spain, Switzerland, Austria and the Netherlands.