DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies today unveiled the CONCORDE LIFT Expandable Interbody Device to European Surgeons at the EUROSPINE 2018 Meeting, taking place in Barcelona, Spain. The CONCORDE LIFT Implant is designed to treat patients suffering from degenerative disc disease by restoring disc height between vertebrae and completes the Company’s UNLEASH MIS TLIF (Transforaminal Lumbar Interbody Fusion) Procedural Solution.
MIS is the fastest growing category in spinal fusion surgery and it is estimated that by 2020, half of all spinal fusion procedures will be performed using a minimally invasive approach.1MIS TLIF has been associated with lower surgical complications, blood loss, muscular damage and pain, with a faster recovery for patients compared to conventional open spine surgery, yet it is associated with a steep learning curve.
This UNLEASH MIS TLIF Procedural Solution was developed by DePuy Synthes Spine to streamline the 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:
- In an anatomic lab study of transforaminal discectomies, surgeons required fewer instrument passes and removed more disc material when using the single-use CONCORDE Clear MIS Discectomy Device compared to standard discectomy tools.
- The CONCORDE LIFT Expandable Interbody Device is inserted once the disc has been cleared.With the reduced insertion size, the surgeon can easily insert and then expand the cage to specifically fit an individual patient’s anatomy without being confined to pre-set intervals. The streamlined instrumentation, suitable for surgeries with limited intervertebral space, 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.
“Minimally Invasive Spine surgery has a lot of immediate and short-term advantages for patients,” said Dr Parajon, Head of Spine, Neurosurgical department, Hospital University Ramón y Cajal, Madrid; and Head of Neurosurgery, Hospital La Milagrosa. “I anticipate that the now complete UNLEASH procedural solution will bring great benefit to surgeons and the entire hospital team.”
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, the MIS TLIF Solution was shown to reduce the total number of instrument passes by 56%(p=0.086) and showed a reduction in procedure time during disc removal, cage implantation and screw placement by 23%(p=.299) compared to a control group of current product offerings. Based on the early indications of this promising bench top study, DePuy Synthes is investing in a health economics 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.
“With the forthcoming introduction of CONCORDE LIFT, we are delighted to be able to offer the complete UNLEASH Procedural Solution to our customers in the EMEA region,” said Jordy Winters, DePuy Synthes Spine Lead EMEA. “This solution provides us with the technology to serve the needs of our customers by reducing the complexities associated with minimally invasive spine surgery.”