Jan 26, 2017 | By Tess

OssDsign, the Swedish manufacturer of next-gen 3D printed cranial and facial implants, recently announced it received 510(k) clearance from the U.S. FDA for its OSSDSIGN Cranial PSI. The FDA clearance means that the Uppsala-based company’s 3D printed cranial implants can now be marketed and sold within the United States.

The company’s flagship product, OSSDSIGN Cranial, is described by the company as a patient-specific medical implant designed specifically for cranioplasty, the process of reconstructing cranial defects. Traditionally, cranioplasty operations use implants made from either bone, inert plastics such as PEEK, or medical-grade metals like titanium. According to OssDsign, however, complications often arise during such cranioplasties (reportedly up to 25%), which necessitate the eventual removal of the implant and more surgery.

With their innovative OSSDSIGN Cranial implant, the Swedish company is aiming to improve cranioplasty processes by offering customized implants based on the patient’s CT scans and optimally manufactured using advanced CAD and 3D printing technologies. Rather than PEEK or titanium, the OssDsign implants are made from a proprietary calcium phosphate composite, which is reinforced with a strong titanium skeleton. According to the company, the implant’s materials and tile-like structure help it to integrate with organic tissues and even promote bone regeneration.

“I believe that OSSDSIGN Cranial is a very promising product for cranial bone reconstruction that has led to positive results within two years follow up after introduction,” commented Lars Kihlström, MD and Senior Consultant of Neurosurgery at Karolinska University Hospital. “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."

With the recent FDA approval, OssDsign plans to bring its 3D printed implants to the U.S. market, which it believes will benefit tremendously from its medical products. As CEO of OssDsign Anders Lundqvist explained: “Receiving FDA clearance for our flagship product OSSDSIGN Cranial is extremely positive news. This means we can continue working according to our existing plan of launching OSSDSIGN Cranial in the US market in Q1 2017. We are in the final stages of setting up an experienced distribution network that will enable OssDsign to rapidly bring the benefits of OSSDSIGN Cranial to surgeons, patients and healthcare systems across the US."

Aside from Sweden (and soon the U.S.), OssDsign currently sells its 3D printed implants in Germany, the UK, the Nordics, Singapore, and Israel. OssDsign also recently announced it has secured commercial partnerships in Italy, Spain, Switzerland, Austria, and the Netherlands.



Posted in 3D Printing Applications



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