3D Systems' VSP Orthopaedics Receives FDA Clearance - MTM

3D Systems’ VSP Orthopaedics Receives FDA Clearance

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 and develop a personalized surgical plan, prior to entering the operating room. The expansion of 3D Systems’ VSP service-based approach into the field of orthopaedic surgery builds on its VSP technology and anatomic modeling leadership.

The new VSP Orthopaedics solution is available through Onkos Surgical’s My3D Personalized Solutions Platform and enables surgeons to devise a precise plan for tumor resection that in some cases allows for the preservation of the native joint. Virtual surgical planning of the patient’s 3D anatomy allows the surgeon to essentially perform the surgery digitally before entering the operating room. Following the online planning session between 3D Systems’ biomedical engineers and the surgeon, patient-specific models, personalized surgical tools, and instruments are designed and 3D printed for use within the sterile field. In clinical applications where VSP is used today, the solutions have been shown to improve surgical accuracy and outcomes — saving time in the operating room, which benefits both the surgeon and the patient.1,2,3 3D Systems fully expects that VSP Orthopaedics will deliver the same benefits to orthopaedic surgeons and patients.

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

Sources:

  1. Sink J, Hamlar D, Kademani D, Khariwala SS: Computer-aided stereolithog-raphy for presurgical planning in fibula free tissue reconstruction of the mandible. J Reconstr Microsurg 28:395-404, 2012.
  2. Patel A, Levine J, Brecht L, Saadeh P, Hirsch DL: Digital technologies in mandibular pathology and reconstruction. Atlas Oral Maxillofacial 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 virtual surgical planning in free fibula mandibular reconstruction: comparison of planned and final results. J Oral Maxillofac Surg 68:2824-2832, 2010.