Amnovis, an additive manufacturing production and engineering company based in Belgium, has delivered over 50,000 3D printed medical implants since 2021.
The company’s heat treatment-free titanium 3D printing process has reportedly shortened the time to market for spinal, orthopedic, and craniomaxillofacial (CMF) implants.
According to Amnovis, its additive manufacturing capabilities have accelerated production speeds and enabled cost savings for those adopting 3D printed medical devices.
One such customer is German medical implant provider Privelop-spine, which has reportedly “reaped the rewards” of this process. The company’s CEO, Henning Kloss, shared that he has been impressed by Amnovis’ production quality and specialist expertise. “Surgeons consistently praise the detailed resolution, look, and feel of our implant structures, while distributors and users appreciate the reliability and punctual delivery,” he added.
Amnovis CEO Ruben Wauthle added that the heat treatment-free 3D printing allows the company to deliver “faster, more cost-effective solutions for our customers while maintaining the highest quality standards.”
A selection of Amnovis-3D printed implants. Image via Amnovis.
Amnovis’ 3D printed titanium implants
Amnovis began 3D printing high-end medical devices in 2008, becoming one of the first companies to produce titanium implants using laser powder bed fusion (LPBF).
According to Kloss, Amnovis’ heat-treatment free titanium 3D printing process significantly streamlined Privelop-spine’s production workflow, reducing time and costs. “Their production capacity and reliability have made a substantial contribution to our collaboration with large customers, helping us bring products to market faster,” he added.
Besides heat-treatment-free manufacturing, Amnovis also offers a full range of more conventional titanium 3D printing services. This includes the production of Ti-6Al-4V grade 23 materials with heat treatments such as Hot Isostatic Pressing (HIP). OEMs therefore have the flexibility to choose the most suitable manufacturing process for their needs.
Earlier this year, the company produced a United States Food and Drug Administration (FDA) Master File. This features key information on all aspects of its qualified titanium 3D printing processes for Ti grade 1 and Ti-6Al-4V grade 23, simplifying the regulatory submissions process. According to Amnovis, the file addresses FDA concerns regarding titanium 3D printing, unlocking faster time to market for 3D printed implants.
3D printing titanium implants. Photo via Amnovis.
The firm’s capabilities are not limited to implants. Last year, Amnovis was selected by medical device firm CairnSurgical to 3D print its patient-specific Breast Cancer Locator (BCL). This surgical guide was designed to help surgeons locate and remove breast tumors during lumpectomies. Available for commercial use in the EU, the BCL is 3D printed using the company’s Stereolithography (SLA) 3D printing technology.
Elsewhere, Amnovis previously collaborated with medical device service provider BAAT Medical to develop a rapid production process for 3D printed medical devices.
Manufacturing on Demand
The two companies, the latter having also exceeded the 50,000 implant mark, created a process spanning initial design stages to manufacturing and validating end-use devices. This is said to unlock faster production speeds for medical device start-ups and OEMs, improving patient outcomes in the process.
Amnovis will showcase its implant 3D printing capabilities at the North American Spine Society (NASS) 39th annual meeting in Chicago from September 25-27. Looking to the future, the company has asserted its commitment to further enhancing its 3D printing process. It will reportedly work to expand its production capacities and scale cutting-edge solutions for spinal, orthopedic, and CMF applications.
A high-volume production run of 3D printed implants. Photo via Amnovis.
The growth of 3D printed implants
The medical sector is increasingly adopting 3D printing, especially for the production of implants. Earlier this year, biomedical 3D printing firm ArcomedLab reportedly broke the record for the most for the most 3D printed craniomaxillofacial implants.
Since 2018, the company has completed 700 successful cases throughout Latin America, including in Chile, Peru, Colombia, and Mexico. 3D printed in a polyetheretherketone (PEEK) biopolymer, the cranial implants are personalized to meet the specific needs of patients.
ArcomedLab produces its personalized 3D printed cranial implants at its facility in Chile. This features a dedicated clean room for fabricating personalized implants and medical devices in a controlled and sterile environment.
Chinese medical firm Wedo Bio-Medical Technology Co, Ltd. announced last year that its 3D printed spinal implant received market approval in China. The Hydroxyapatite-Coated Porous Titanium Alloy Interbody Fusion Device, or WedoCage, is 3D printed using technology from Chinese 3D printer manufacturer Bright Laser Technologies (BLT).
The device obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration. WedoCage incorporates a sophisticated and complex porous structure, demanding a high level 3D printing precision.
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Author: Alex Tyrer-Jones
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