The To-Do List
The post purchase honeymoon is over so Centinel’s to-do list is where the action is.
First up is nailing down indications and patient selection.
For cervical, that’s relatively well established. The clinical objective is to address discogenic pain, restore disc height, and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease.
And, of course, reduce the risk of subsequent adjacent disc degeneration.
Next is updating the cervical product offering.
Since the Viscogliosi Brothers sold ProDisc to Synthes, cervical disc arthroplasty has become a comparatively hot area in the otherwise slow growth spine industry.
Both LDR’s Mobi-C and Medtronic’s Prestige are approved for two levels. Orthofix is buying Spinal Kinetics M-6 cervical implant and will likely have FDA approval for a single level in the coming 12 months.
Each of these companies have successfully brought impressive designs for fixation and articulation to spine surgeons and have market momentum.
Synthes had two new ProDisc cervical disc arthroplasty designs in Europe and now Centinel Spine is laying the groundwork to bring them to the U.S. and through the FDA approval process.
They are ProDisc-C Vivo (Figure 1) and ProDisc-C Nova (Figure 2).
While the basic articulating mechanism of action is the same for both implants, the fixation is different.
ProDisc-C Vivo uses teeth fixation and anatomic endplates to provide high primary stability and multilevel capability for patients with domed endplates. The ProDisc-C Nova uses an updated version of the classic ProDisc keel and it is intended for patients with a relatively flat endplate contour.
Neither are currently available on the U.S. market. Centinel is starting the IDE FDA study programs, including 1- and 2-level trials as well as Vivo/Nova and STALIF-C hybrid construct studies.
ProDisc-C Vivo has been available outside the U.S. since 2012 and has been implanted 14,000 times worldwide. Its primary features include a convex superior plate for anatomical fixation and a trapezoidal footprint design for optimal anatomical fit and maximum endplate coverage.
Like all ProDisc implants, the superior and inferior endplates are made with CoCrMo (cobalt–chromium–molybdenum) while the surface coatings are a rough, pure titanium for bony ongrowth. The inlay is ultra-high molecular weight polyethylene (UHMWPE) and articulation is UHMWPE on CoCrMo.
ProDisc-C Vivo has a center of rotation which is located just below the inferior endplate of the prosthesis. Pure translation movements are controlled by the mechanism of action interface.
Centinel’s ProDisc-C Nova has been available outside the U.S. since 2010 and has been implanted more than 7,500 times.
The ProDisc-C Nova TDR (total disc replacement) is the next-generation of ProDisc-C. Among the features is an updated double keel design on the caudal endplate, which supports multi-level implants, and updated materials for better MRI imaging.
Since most patients who are indicated for cervical motion preserving implants require a multi-level surgery, the updated design of the ProDisc-C Nova is tailored for these cases.
Finally, the last item on Centinel’s to-do list is training.
Centinel requires that all (100%) surgeons and distributors/reps receive ProDisc training.
