Orthofix Medical, a global medical device company with a spine and orthopedics focus, today announced the U.S. launch and first patient implant of the FORZA™ Ti PLIF Spacer System. Developed to enhance Posterior Lumbar Interbody Fusion (PLIF) procedures, the 3D-printed FORZA Ti Spacer with Nanovate™ Technology is a titanium lumbar interbody device featuring an optimized design, porosity and surface that allows bone to grow into and through the spacer.
“Posterior lumbar interbody fusion involves inserting an interbody device between the vertebrae during a spinal fusion surgery to help relieve pressure on nerves and hold the vertebrae in place while fusion occurs,” said Dr. Joel Siegal, a neurosurgeon at St. Vincent Charity Medical Center in Cleveland, Ohio, who performed the first implant procedure. “Being able to maximize bone ingrowth is critical to the success of the fusion process. The large opening for packing bone grafting materials and the 3D-printed titanium endplates of the FORZA Ti Spacer are well designed to aid in our goal of maximizing bone ingrowth to aid fusion.”
Features of the FORZA Ti PLIF Spacer System include:
- Large open graft window for packing bone-grafting material
- Bulleted nose to assist with distraction
- 3D-printed porous titanium with macro, micro, and nanoscale surface features
- Nanoscale surface that has been shown to increase proliferation and alkaline phosphatase activity (an early osteogenic differentiation marker) in human stem cells in vitro*
- Functional gradient porous structure with 80-percent porosity at the midline of the implant which allows for increased fluoroscopic visualization
- Endplates with 400 micron pores and 50-percent porosity designed to help facilitate bone ingrowth**
- Endplates consisting of interconnected gyroid structures analogous in form to trabecular bone which provide an open porous environment
The FORZA Ti PLIF Spacer System with Nanovate Technology is available in the U.S. through a targeted commercial release.
“The FORZA Ti PLIF Spacer System, featuring Orthofix’s unique Nanovate Technology, is one of several new 3D-printed titanium products we have launched recently and highlights our commitment to delivering innovative solutions to the market,” said Orthofix President of Global Spine Kevin Kenny. “The FORZA Ti system is also ideal for use with our flagship Trinity ELITE™ allograft with viable cells that supplies the essential components for new bone formation.”
The FORZA Ti PLIF Spacer System is one of many products that feature Orthofix’s Nanovate Technology including the recently launched FORZA TI TLIF Spacer System, CONSTRUX Mini Ti Spacer System, CONSTRUX Mini PTC Spacer System, Pillar™ SA PTC Spacer System, and the FORZA™ PTC Spacer System.
*As suggested in an in vivo ovine lumbar spinal fusion model
**In vitro performance may not be representative of clinical performance