3D Systems Secures FDA Clearance for VSP Orthopedics Platform Expansion
Rock Hill, South Carolina-based 3D Systems recently announced that it has received FDA 510(k) clearance to expand the indications for its Virtual Surgical Planning (VSP) Orthopedics platform. This expansion now includes applications for skeletally mature adolescents presenting with normal bone stature, marking a significant step forward for orthopedic care in this demographic.
As reported in a December 15 press release, this important regulatory approval streamlines the treatment processes for adolescent patients by eliminating the previously required compassionate-use protocols or institutional review board (IRB) approvals. The change allows healthcare providers to offer standard, reimbursable care, thus facilitating access to essential orthopedic interventions.
Osteosarcoma and Ewing sarcoma are among the most prevalent bone cancers affecting individuals aged 20 and under, with over 1,200 new cases identified annually in the United States, according to data from the American Cancer Society. The landscape for young adults and adolescents also includes approximately 2,600 bone cancer cases and a need for deformity reconstructions. The expanded use of the VSP Orthopedics platform aims to address these critical healthcare needs, providing tailored surgical solutions for a vulnerable patient population.
3D Systems has a proven track record, having completed over 400,000 patient-matched cases. It stands out as the sole FDA-cleared provider of virtual surgical planning in several fields, including craniomaxillofacial and orthopedic procedures. The company indicated that its VSP platform relies on existing Current Procedural Terminology (CPT) and Diagnosis Related Group (DRG) codes, which supports the reimbursement process for healthcare providers.
The implications of this clearance are substantial for both the company and the broader medical technology sector. 3D Systems anticipates that this new FDA clearance will bolster continued double-digit growth in its medical technology segment, reflecting the increasing demand for innovative orthopedic solutions that leverage advanced 3D modeling and planning technologies.
With the expansion of the VSP Orthopedics platform, 3D Systems is poised to enhance surgical outcomes for adolescent patients while reinforcing its position as a leader in the field of orthopedic innovation. This development not only represents a win for the company but also a milestone in improved surgical care accessibility for young patients facing significant health challenges.
