FDA clears 3D Systems’ VSP Orthopedics for adolescent patients
3D Systems, Rock Hill, South Carolina, USA, has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its VSP Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents of normal bone structure.
This commercial acceleration is anticipated to eliminate case-by-case, compassionate-use approvals and hospital institutional review board (IRB) reviews previously required when using the VSP Orthopedics for adolescent patients, thus streamlining workflows and the conversion of off-label use into standard procedures.
Thousands of complex lower-limb osteotomies and reconstructive procedures are required by younger patients each year due to issues stemming from primary bone cancers or congenital, developmental or traumatic defects.
3D Systems’ VSP Orthopedics cases generate service fees for virtual planning combined with revenue from patient-specific additively manufactured models and single-use surgical guides (e.g. titanium osteotomy guides for maxillofacial surgery) produced on 3D Systems’ Additive Manufacturing machines.
“This regulatory clearance removes a significant friction point for adoption in the paediatric/adolescent orthopaedic oncology segment,” stated Ben Johnson, senior vice president of medical technology at 3D Systems. “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 US adolescent bone sarcoma and deformity market to our platform. We are thrilled to now offer these solutions to an expanded and underserved patient population.”
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Financial returns
3D Systems anticipates that the revenues resulting from this 510(k) clearance expansion will contribute to the strong, double-digit annual growth rates and accretive gross margins of the company’s medical technology business.
The company further stated that it is the only provider of FDA-cleared VSP solutions spanning craniomaxillofacial, orthopaedics and, to date, has delivered over 400,000 patient-matched cases and devices. It added that the expansion of indications is expected to translate to double-digit average annual growth for its Healthcare segment.
