3D Systems, a 3D-printed additive manufacturing solutions company, has announced the Food and Drug Administration (FDA) clearance for its 3D-printed, called VSP PEEK Cranial Implant, to deliver patient-specific cranial reconstruction solutions. The solutions include a complete FDA-cleared workflow comprising segmentation and 3D modeling software, Evonik VESTAKEEP i4 3DF PEEK, the 3D Systems EXT 220 MED 3D printer, and a pre-defined production process.
Using additive manufacturing solutions to produce patient-specific cranial implants with up to 85% less material than traditional implants, also can help to save significant costs for an expensive raw material like implantable PEEK (polyetheretherketone).
Moreover, the cleanroom-based architecture of the printer combined with simplified post-processing workflows also makes it promising for the production of patient-specific medical devices at the hospital site as it has a faster turnaround and keeps the overall cost under control.
The VSP PEEK Cranial Implant is also the first additively manufactured PEEK implant to get the FDA clearance that helps to restore defects in the skulls. PEEK has been long well-known in clinical history in medical device applications as an implant-grade, high-performance polymer thanks to its exceptional performance with mechanical properties closely mirroring human bone.
It’s also an ideal choice for many medical device applications because it not only has excellent biocompatibility, and resistance to bodily fluids, but stability in a wide range of temperatures. In addition to those, its inherent radiolucency also helps to minimize interference in medical imaging but still can give a clearer evaluation of the surgical site and implant integrity.
In more than a decade, 3D System has worked with surgeons to study and plan over 150,000 patient-specific cases and manufacture more than two million implants and instruments for over 100 CE-marked and FDA-cleared devices from its world-class, which are not only registered by FDA but certified ISO 13485 by facilities in Littleton, Colorado and Leuven, Belgium.
The VSP PEEK Cranial Implant has been used to enable nearly 40 successful cranioplasties in Europe. With the FDA clearance, it is expected to bring the VSP PEEK Cranial Implant to the U.S.
This technology is also hoped to expand to other applications, such as 3D-printed spine interbody fusion implants, carbon fiber-reinforced PEEK for plating applications in trauma and fixation, or bioresorbable polymers for large bone and craniomaxillofacial applications.
Article & Image Source: 3D Systems
