3d systems announces fda clearance for world's first 3d-printed peek cranial implants
Rock hill, s.c., april 15, 2024 (globe newswire) -- today, 3d systems (nyse:ddd) announced the food and drug administration (fda) has provided 510(k) clearance for its 3d-printed, patient-specific cranial implant solution — vsp® peek cranial implant. vsp peek cranial implant includes a complete fda-cleared workflow comprising segmentation and 3d modeling software, the 3d systems ext 220 med 3d printer, evonik vestakeep ® i4 3df peek (polyetheretherketone), and a pre-defined production process. by utilizing additive manufacturing solutions, this technology can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining, which can lead to significant cost savings for an expensive raw material like implantable peek. furthermore, the cleanroom-based architecture of the printer combined with simplified post-processing workflows makes it an ideal technology for producing patient-specific medical devices at the hospital site with faster turnaround while keeping the overall cost under control. to date, this solution has been used to enable nearly 40 successful cranioplasties in switzerland at university hospital basel, in austria at salzburg university hospital, and in israel at tel-aviv sourasky medical center.
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