Kleiner Device Labs has announced final approval by the Department of Veterans Affairs (VA) for making the Kleiner KG 1 lumbar spinal bone graft tool available to VA and military surgeons through Government Marketing and Procurement, a CVE Verified Service Disabled Veteran Owned Small Business, on its VA FSS Schedule 65llA contract.
In its peer-reviewed published clinical testing, the KG 1 improved the lumbar spinal fusion group’s success rate from 75% to 92%1, without the use of BMP. This reduced the relative number of revision surgeries by 32%. To facilitate better graft delivery, the KG 1 has more than double the inside dimension of conventional funnels; bi-portal ejection zones for better graft fill volume and distribution; a removable funnel cup; and a wedged tip with a radiographic marker.
The device’s rectangular shape and size leave a perfect void, upon removal, for introduction of a fusion cage. Location of the extrusion ports 2mm from the tip also facilitates backfilling after placement of a banana-style cage. Free sterile samples are available for surgeons to trial.
“As a full-time spine surgeon doing all minimally-invasive work, I personally feel the KG 1 device is exactly what spine surgeons look for, simplicity and excellent functionality,” said James Leipzig, MD, who began using the KG 1 in 2019.
“The device allows me to precisely insert it into the disc space, with fluoroscopic confirmation, and then fill the disc space with three to four times the volume I used to place. I place the device once, and therefore avoid the risk of a CSF leak or root injury with multiple placements of a funnel. When the device is removed, a channel is naturally formed for the implant.”
The KG 1 is a proven tool for making surgeons lives easier in the operating room, and improving outcomes for patients, and those who pay for their care. VA and military hospitals should expect to realize significantly reduced costs, and happier veteran patients.
GMP is a nationally recognized Service Disabled Veteran Owned contract management firm that is the primary link between top-performing IT, medical and security solution providers and Government buyers.
Kleiner Device Labs is creating new tools to advance minimally invasive spine surgery and improve outcomes and costs for patients, surgeons, hospitals and payers.
Source: Company Press Release