Spineology has announced the completion of the first post-market study cases using its recently FDA-cleared Duo Lumbar Interbody Fusion System. In October, the company announced the initiation of this prospective, post-market lateral interbody fusion study designed to evaluate patient outcomes.
To date, study cases have been completed by Craig Kuhns, Austin, USA, Sandeep Kunwar, Fremont, USA, and Jason Huffman, Napa, USA.
The Duo System implant is the first to combine PEEK, titanium and graft containment mesh elements. According to the company, this design reduces the access required to implant a device compared to traditional lateral systems. By significantly minimising the nerve and soft tissue retraction typically required in these surgeries, the company believes the Duo System will reduce the post-operative thigh pain and other complications commonly associated with the lateral approach.
In addition to reducing the exposure required for placement, the Duo implant, once filled, creates a large, load-sharing, endplate-conforming graft pack that expands up to 30mm in width to help maintain spinal correction and support fusion.
“The Duo System allows me to efficiently place the implant through a very small access, which reduces trauma to the muscle and neural elements,” said Kunwar. “During placement, the implant can immediately correct spinal deformity. Once in place, the implant is filled with allograft and provides a very large footprint, resulting in excellent stabilisation of the segment and a large area for fusion.”
“Thigh-related post-operative complications associated with the lateral approach have been well documented,” said Kuhns. “Based on my experience, the Duo System has the ability to significantly reduce these complications, which makes for a much easier postoperative course for my patients.”
“The Duo System is intuitively designed,” added Huffman. “The small, 18mm tubular access portal reduces trauma to soft tissues and neural structures while significantly minimising tissue creep. It also eliminates the need to position blades, saving me time during the procedure. The instrumentation allows for an efficient, radical discectomy and timely placement of the implant. The reduced access requirements and efficiency of the system both play a role in the reduction of post-operative thigh pain and weakness, and the overall success of the surgery.”
Additional sites nationwide are participating in the Duo System post-market study and are currently completing training or screening patients.