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FDA Approved: OssDsign AB Will Now Offer 3D Printed Cranial Implant Technology in US

ST Medical Devices

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download-29While the impacts of 3D printing are being seen around the world and in nearly every major industry, it’s hard to imagine what could be more important than the progress we are seeing in the medical field today. With the opportunities to customize medical devices, implants, and much more, medical professionals are able to offer patient-specific care to those in need.

Medical implants are one of the fields that has really seen progress due to 3D printing, and this will continue further now as OssDsign AB brings their next generation cranial and facial reconstruction implants to the US from Sweden, following their 510(k) FDA clearance for OSSDSIGN Cranial PSI. Created by surgeons and material scientists, this new product will aid further in cranioplasty, as cranial defects are repaired.

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“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,” said Anders Lundqvist, CEO of OssDsign.

“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.”

 The 3D printed medical implant offers a wealth of benefits. Most importantly, the OSSDSIGN Cranial PSI helps to prevent infections that are so common in more traditional procedures involving implants created with the patient’s own bone matter, or constructed out of metal. The 3D printed implant can also be completely customized to fit the patient through CAD design and then 3D printing of each implant, made with a proprietary calcium phosphate composite material that is strengthened further with a robust titanium framework.

“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,” said Lars Kihlström, MD, 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.”

And while OSSDSIGN cranial implants will be new in the US, they are already being introduced all over the world, along with other products that the Swedish company produces. OSSDSIGN products have been available in Europe since 2014 in Germany, the UK and the Nordic region, along with Israel and Singapore. The company reports that in early January they also began working with other commercial partners so that their 3D printed medical implants can be sold in Italy, Spain, Switzerland, Austria and the Netherlands.

Dedicated to facial and cranial reconstructions, OssDsign offers customized implants for patients due to the collaborative work of researchers from Karolinska University Hospital in Stockholm, and material science experts at the Ångström Laboratory at Uppsala University. Find out more about OssDsign here. Discuss in the OssDsign forum at 3DPB.com.

[Source / Images: OssDsign]

 

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