The FDA has cleared OssDsign to market its personalized 3D-printed cranial implants in the U.S. The titanium-reinforced calcium phosphate composite device is designed to give neurosurgeons an alternative to the patient’s own bone or inert material implants when reconstructing cranial defects.
OssDsign creates each device by looking at a patient’s CT scan and plotting out the implant that will best meet their needs using computer-assisted design software. The resulting blueprint is then produced using a 3D printer, resulting in an implant tailor-made to repair a patient’s cranial defect.
The implants are made from a proprietary calcium phosphate composite that is strengthened by a titanium skeleton. OssDsign thinks this design results in a lower rate of complications, such as infections, than bone-based reconstructions or implants made of plastics or metals. In some cases, these complications force surgeons to remove the implant, putting the patient at risk and adding to healthcare costs.
Retrospective study data presented by OssDsign last year showed that after an average of 9.5 months, 96.7% of patients who received its implants were free from complications that necessitated implant removal.
Those data added weight to anecdotal evidence accrued by OssDsign since it introduced the implant in Germany, the United Kingdom and other European countries.
“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,” Lars Kihlström, M.D., senior consultant of neurosurgery at Karolinska University Hospital, said in a statement.
Having secured FDA 510(k) clearance, OssDsign expects to start selling the implants in the U.S. this quarter. The rollout adds to a busy period for the Swedish medtech company, which started 2017 by penning commercial partnerships that move it into Italy, Spain, Switzerland, Austria and the Netherlands. Work to win approval in Japan is underway.