The U.S. Food and Drug Administration has granted 510(k) clearance to 3D Systems, allowing its VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to benefit a broader selection of patients.
The expansion of the indication includes skeletally mature adolescents of normal bone stature, in addition to adults.
Following the expanded FDA indication, case-by-case compassionate-use approvals and hospital IRB reviews previously required for adolescent patients will be eliminated. 3D Systems also expects workflows to be streamlined and for standard, reimbursable procedures to be enabled.
The company is now targeting what it describes as an underserved segment, with over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20 according to estimates by the American Cancer Society. There are also an additional 2,600 primary bone cancer cases in young adults (20–39) 'now fully in scope', as well as thousands of complex lower-limb osteotomies and reconstructive procedures annually for congenital, developmental, and trauma-related deformities in adolescents.
For 3D Systems, the company believes VSP Orthopedics cases will generate service fees for virtual planning combined with revenue from patient-specific 3D printed anatomic models and single-use surgical guides produced on 3D Systems’ additive manufacturing platforms. For healthcare service providers, procedures are covered under existing DRG/CPT codes for tumour resection, osteotomy, and reconstruction with no changes required.
Ben Johnson, Senior Vice President of Medical Technology at 3D Systems, said: “This regulatory clearance removes a significant friction point for adoption in the pediatric/adolescent orthopaedic oncology segment. Surgeons at leading centres have been using off-label or compassionate use solutions for years; this decision immediately converts those cases into routine clinical practice and opens the U.S. adolescent bone sarcoma and deformity market to our platform. We are thrilled to now offer these solutions to an expanded and underserved patient population.”
