3D Systems' VSP Orthopaedics Receives FDA Clearance

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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.

3D Systems announced that the Food and Drug Administration(FDA) has provided 510(k) clearance to its new VSP Orthopaedics solution ­­­—enabling surgeons to obtain a clear 3D visualization of a patient's anatomy anddevelop a personalized surgical plan, prior to entering the operating room. Theexpansion of 3D Systems' VSP service-based approach into the field oforthopaedic surgery builds on its VSP technology and anatomic modelingleadership.

The new VSP Orthopaedics solution is available through OnkosSurgical's My3D Personalized Solutions Platform and enables surgeons to devisea precise plan for tumor resection that in some cases allows for thepreservation of the native joint. Virtual surgical planning of the patient's 3Danatomy allows the surgeon to essentially perform the surgery digitally beforeentering the operating room. Following the online planning session between 3DSystems' biomedical engineers and the surgeon, patient-specific models,personalized surgical tools, and instruments are designed and 3D printed foruse within the sterile field. In clinical applications where VSP is used today,the solutions have been shown to improve surgical accuracy and outcomes — savingtime in the operating room, which benefits both the surgeon and the patient.1,2,33D Systems fully expects that VSP Orthopaedics will deliver the same benefitsto orthopaedic surgeons and patients.

As a pioneer in the personalized medicine space, 3D Systemsestablished VSP in 2012 as a service-based approach to personalized surgery,combining expertise in medical image processing, surgical planning, design, and3D printing.

Sources:

  1. Sink J, Hamlar D, Kademani D, Khariwala SS:Computer-aided stereolithog-raphy for presurgical planning in fibula freetissue reconstruction of the mandible. J Reconstr Microsurg 28:395-404, 2012.
  2. Patel A, Levine J, Brecht L, Saadeh P, HirschDL: Digital technologies in mandibular pathology and reconstruction. Atlas OralMaxillofacial Surg Clin N Am 20:95-106, 2012.
  3. Roser SM, Ramachandra S, Blair H, Grist W,Carlson GW, Christensen AM, Weimer KA, Steed MB: The accuracy of virtualsurgical planning in free fibula mandibular reconstruction: comparison ofplanned and final results. J Oral Maxillofac Surg 68:2824-2832, 2010.

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