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3d Systems Attains FDA Clearance For Virtual Surgical Planning Platform
Leading 3D printer OEM 3D Systems has attained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VSP Orthopaedics platform. Offered exclusively through Onkos Surgical’s My3D™ Personalized Solutions Platform, VSP Orthopaedics is used for the virtual surgical planning of complex procedures. It can be combined with 3D Systems’ other areas of expertise to design and 3D print anatomical models and cutting guides for further surgical aid.
The platform is part of 3D Systems’ strategic approach to forge a strong position within the 3D healthcare sector. Recently, the company has also received 510(k) clearance for its D2P™ (DICOM-to-PRINT) software, specifically designed to help clinicians 3D print anatomical models.
Radhika Krishnan, SVP software & healthcare at 3D Systems, commented, “Based on the success we’ve seen with our personalized healthcare solutions in other surgical specialties, we are confident in the positive impact on patient care this technology will have for the orthopaedic community.”
3D Systems Virtual Surgical Planning
VSP Orthopaedics is one part of the wider Virtual Surgical Planning solution offered by 3D Systems. The foundations of 3D Systems VSP were reportedly laid 25 years ago and have, since then, helped with more than 120,000 patient cases. As of January 2018, a range of 3D Systems Virtual Surgical Planning options are available though American medical technology firm Stryker, which works with 3D Systems to provide the service under the assistance of specialist biomedical engineers. Presently however, the VSP Orthopaedics offering is only available through technology offered by Onkos Surgical.
having achieved 510(k) clearance from the FDA, it now means that VSP Orthopaedics is “at least as safe and effective” to another legally marketed device, signifying it appropriate for safe application.
Ethos behind the Onkos Surgical My3D™ Personalized Solutions Platform. Image via Onkos Surgical
Improving surgical outcomes
Founded in 2015, Onkos Surgical is a specialist provider of medical implants and instruments for the treatment of musculoskeletal tumor patients. The company is based in Parsippany, New Jersey, and in 2017 it received $17.6 million in Series B funding from three investors, including 3D Systems.
Onkos’ My3D™ Personalized Solutions Platform is used to develop personalized implants, instruments, and anatomic model designs for surgeons. With integrated VSP Orthopaedics, the platform has added capacity of the precise planning of tumor resection, which in some cases allows for the preservation of the native joint. The solution can help improve surgical outcomes and save time in the operating room.
“As an early-stage investor in Onkos,” commented Patrick Treacy, CEO, Onkos Surgical, “3D Systems understands our passion for developing innovation.”
“The VSP Orthopaedics System, which is available exclusively through our My3D Personalized Solutions platform is a great example of how we’re harnessing the power of advanced surgical planning and personalization to create novel solutions that musculoskeletal patients deserve.”
3D Systems’ FDA cleared VSP Orthopaedics solution enables surgeons to obtain a clear 3D visualization of a patient’s anatomy and develop a personalized surgical plan, prior to entering the operating room. Image via 3D Systems
