During spinal fusion surgery, the degenerated disc is removed and the CONCORDE LIFT Expandable Interbody Device is implanted in its place to help restore the disc height between the two vertebrae in the spine.
"I've had the privilege of performing one of the first cases of spinal fusion surgery using the CONCORDE LIFT Implant in the United States and have been very happy with what I have been able to achieve using this device," said John Hall, M.D., Spine and Orthopaedic Trauma Surgeon. "I believe that being able to access the disc through a small space and then controllably expanding the cage to fill the disc space allowed me to achieve a reliable fusion."
By 2020, it is estimated that half of all spinal fusion procedures will be performed using a minimally invasive approach.1 While it has a steep learning curve, minimally invasive spine surgery has been associated with reducing complications, blood loss, muscular damage and pain, with a faster recovery for patients compared to conventional open spine surgery.2,3
This MIS TLIF Procedural Solution was developed by DePuy Synthes Spine to simplify key stages of the MIS TLIF surgery and additionally includes the CONCORDE Clear MIS Discectomy Device and the VIPER PRIME System for percutaneous pedicle screw insertion. Here are the steps involved in the procedure:
- The single-use CONCORDE Clear MIS Discectomy Device allows the degenerated disc-clearing process to occur with fewer instrument passes while increasing the amount of disc material removed compared to standard discectomy tools.4
- The CONCORDE LIFT Expandable Interbody Device is inserted once the disc has been cleared. With this implant, the surgeon can expand the cage to specifically fit the cage to an individual patient's anatomy without being confined to pre-set intervals. The streamlined instrumentation provides tactile feedback during the expansion maneuver and the system offers surgeons the option to back-fill the space with bone graft even after the cage has been fully expanded.
- The VIPER PRIME System, aimed at efficiency, combines multiple instruments into one screw inserter tool enabling the surgeon to perform percutaneous pedicle screw insertion in a single instrument pass.
This new offering exemplifies the company's commitment to innovative platforms that are designed to reduce surgical complexity, improve patient outcomes and decrease costs. In an anatomic lab study, this MIS TLIF Solution suggested a potential reduction in instrument passes and showed a reduction in procedure time during disc removal, cage implantation and screw placement compared to a control group of current product offerings. Based on the early indications of this promising cadaveric study, DePuy Synthes is investing in a health economic study in addition to a clinical study to evaluate the potential benefits of the UNLEASH MIS TLIF Procedural Solution as compared to traditional MIS TLIF procedures.
"This UNLEASH Solution delivers a new offering to help reduce the complexity associated with minimally invasive spine surgery while reducing costs and OR footprint," said Nadav Tomer, Worldwide President, DePuy Synthes Spine. "DePuy Synthes is committed to innovating the tools and technology required to serve more patients globally in a range of care settings by delivering disruptive procedural solutions that improve outcomes supported by real world clinical and economic evidence."
1 Huang, Tsung-Jen. The State of the Art in Minimally Invasive Spine Surgery. Biomed Res Int. 2017. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5350391/.
2 Peng, CW et al. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9.
3 Phan, K et al. Minimally invasive versus open transforaminal lumbar interbody fusion for treatment of degenerative lumbar disease: systematic review and meta analysis. Eur Spine J 24:1017-1030. 2015.
4 Lavelle, W et al. An In Vitro Study Examining a Novel Suction Curette Device for Lumbar Discectomy Compared with Standard Manual Discectomy. J Neurosurg Spine 26:454-458. 2017.