Incline Village, Nevada-based Kleiner Device Labs (KDL) has announced that the first 50 cases are now in the books for their novel KG®2 Surge® flow-thru interbody system.
The official announcement came at the Southern Neurosurgical Society’s 2024 annual conference in Orlando, Florida. According to the company, the KG 2 Surge system reduces risks from poor/insufficient graft volume and placement, surgical site infection (SSI), collateral tissue damage due to multiple instrument passes, and from lengthy OR time.
According to Kleiner Labs the first 50 cases with the new KG 2 Surge used an average of 10ml of bone graft delivered per disc space and an average of eight minutes total elapsed time for trial, cage placement, grafting and release of the implant.
“Posterior approach spine fusion has a number of inherent risks to patients’ health and successful outcomes, as well as significant frustrations for surgeons, and those became the key objectives of our re-engineering a complete interbody system,” said Jeff Kleiner, M.D., KDL founder and CEO.
“One thing that stands out about our development process is the feedback we got from surgeons who tried it in our first cadaver verification/validation lab with four active surgeons in April of 2022,” added Dr. Kleiner.
“Surgeons were given a chance to trial the KG2, both in open and MIS procedures. The feedback from that lab was incredibly gratifying to me and the engineering team, and helpful in understanding how best to introduce KG2 to surgeons in the market. All surgeons were delighted and amazed at how easily the system worked, how much graft they could get into the disc space and how simple and time efficient it was.”
“We had set out to address one of the key failure factors in spinal fusion surgery—getting adequate graft into the prepared disc space to promote a biologically based fusion. Improving the volume of delivered graft was anticipated to improve the fusion failure rate, which has historically averaged 1-in-4.”
“We also designed our proprietary flow-thru technology, complete system and single patient use set approach to address a number of challenges faced by most surgeons: unnecessary steps, cross-contamination, and dependency on central supply.”
According to Dr. Kleiner, here were some of the comments surgeons had about the KG2 system:
- “Solved the fussiest part of the spinal fusion surgical process.”
- “Eliminated the fiddle factor.”
- “It takes the guesswork out.”
- “More graft and less tedious grafting.”
“One of the most captivating observations that was made from analysis of the KG 2 initial launch data was that nine different surgeons were able to apply an average of 10ml of graft material to the prepared disc space and this was independent of the graft flowability. The KG 2 system demonstrated that it was agnostic to graft type or consistency.”
“Another interesting observation from the KG 2 initial launch data was that the combination of multiple steps into a single surgical pass saved so much time. We had anticipated that it would be a time saver, but the fact that determining the size of the implant, inserting the KG 2, grafting the disc space, and releasing the implant would only take an average of eight minutes was remarkable.”
Making the Posterior Approach Attractive Again
As for how this may shift surgeons’ thinking on the posterior approach, Dr. Kleiner told OTW, “I think the KG 2 system will reawaken the surgeon’s interest in posterior approaches because it simplifies and standardizes the tedious and potentially injurious process of grafting the disc space during interbody procedures.”
“The pre-assembled and pre-sterilized system reduces the training necessary for the operating room team and virtually eliminates the cross-contamination of surgical instruments because there is no touching of the implant necessary before its insertion, nor is there pre- or post-packing of graft material.”
“Posterior operations provide a great deal of benefit for the patient because they provide a familiar approach for most surgeons and allow a reliable and direct decompression of neural elements. One of the challenges of the posterior fusion was reliably grafting the disc space during an interbody posterior approach. The resultant ‘graft insecurity’ was especially evident in minimally invasive procedures and led to the dependence on chemical adjuvants in many procedures. The KG 2 system is graft agnostic and allows for sufficient graft volume to maximize the quality and volume of graft material applied. This process is independent of surgical approach and technique and allows for less expensive alternatives for grafting the disc space.”
