New Kleiner Spine Graft Delivery Tool Improves Outcomes for Patients, Surgeons, Hospitals and Payers 

PRESS RELEASE

FOR IMMEDIATE RELEASE 

New Kleiner Spine Graft Delivery Tool Improves Outcomes for Patients, Surgeons, Hospitals and Payers 

Denver, January 10, 2018 – Kleiner Device Labs today announced full commercial availability of a new spinal bone graft delivery tool, the KG1, featuring a patented design that facilitates less-invasive procedures and has been proven in clinical testing to reduce spinal fusion failure rates by 68%1. 

“In my own surgical practice, I was frustrated by unacceptable failure rates in spinal fusions and bad outcomes for my patients that were driven by existing graft delivery tools that jam, don’t distribute graft material to the right locations or quantity, or required excessive manipulation that creates soft tissue inflammation or damage. The round, end dispensing tools left me frustrated and with ‘am I done yet?’ questions,” said Jeff Kleiner, M.D., founder and CEO of Kleiner Device Labs. 

“In testing, we found that the KG1’s design solves all these problems, and use of the new tool, alone, improved my spinal arthrodesis rate from 75% to 92%1,” added Kleiner. 

The benefits for patients include higher success rates and far fewer remedial second surgeries, less post-operative pain and infection risk, and less use of bone morphogenetic protein (BMP). 

For surgeons, the KG1 facilitates less-invasive procedures, faster surgeries, and reduces frustrations and guesswork in the OR. 

Michael J. Rauzzino, M.D., of Front Range Spine and Neurosurgery in Denver, added, “I have found that I have been able to get a great deal more graft material into the disc space in a much more quantifiable and rapid fashion. The delivery device has been very simple and easy to use and I have used it for both minimally invasive as well as in open applications. It has been particularly helpful for me in the minimally invasive fusions we do, greatly increasing the amount of bone graft material that I have been able to get into the interspace. I have also found it extremely helpful for our minimally invasive lateral approaches to the spine where due to the depth of the wound and the anatomy, it was difficult to get a good deal of bone graft into the interspace.” 

Srdjan Mirkovic, M.D. of NorthShore Orthopedic Institute in Chicago added, “Over the last five months in my T-lif and L-Lif operations, I have been able to expedite bone graft insertion for these procedures and avoid the problems that I encountered with round, end-dispensing bone funnels including cannula tip visualization, jamming, injury to the bony end plates of the disk space and failure to distribute bone graft in the disk space. I found that I was able to introduce more scaffold and cells and still have room for my fusion cage. It has decreased my operating time, eliminated the frustration and challenge of interbody grafting and improved my early fusion results without using BMP. It has worked well with all of the flowable graft extender and ground autograft that I have used.” 

For hospitals and payers, facilitating surgeons’ use of the KG1 can reduce the costs of spinal fusion surgery through reducing the number of remedial procedures, higher OR throughput and reduced use of BMP. 

The patented KG1 graft delivery tool includes a cannula, plunger and detachable funnel, which facilitates easier loading of graft material. The KG1’s unique shape allows easier entry into the disk interspace, minimizing soft tissue damage or irritation. The bi-portal design ejects graft material to fill both sides of the disk space while leaving a central void for insertion of a fusion cage. The KG1 is disposable, guaranteeing sterility of the instrument and eliminating the system costs of cleaning and restocking. Made of Lexan®, the KG1 has been strength tested and proven beyond normal surgical applications. 

The KG1 is available commercially from the company and through authorized distributors, as well as to Veterans Administration and military healthcare facilities on the GSA schedule through Government Marketing & Procurement

For KG1 technical specifications, instructions for use, or clinical efficacy information, please go to www.kleinerlabs.com/kg1

About Kleiner Device Labs 
Kleiner Device Labs is creating new tools and devices to advance minimally invasive spine surgery and improve outcomes and costs for patients, surgeons, hospitals and payers. Kleiner Device Labs is headquartered in Incline Village, California. More information is available on the company’s web site at http://www.kleinerlabs.com/

Lexan is a registered trademark of Sabic Global Technologies B.V. 
KG is a registered trademark of Kleiner Device Labs/Spinal Surgical Strategies 

1 Kleiner, et. al., Med Devices and Tech, 2016 

Media and Investor Contact: 
Brad Samson 
Kleiner Device Labs 
brad.samson@kleinerlabs.com 
714.955.3951

A Novel Tool for Delivery of Bone Graft to the Disk Space

Bone graft delivery to the intervertebral disk space is a critical step in achieving a spinal fusion. This published manuscript describes a novel tool for efficiently transporting bone graft to disk space.

MANUSCRIPT EXCERPT:

INTRODUCTION
A variety of instrumentation techniques are available to assist with lumbar interbody stabilization. These include different approaches for placing fusion cages (oblique, lateral, anterior, or posterior), using stackable cages, expandable cages, and the application of cage coatings. Although this is a limited inventory, these available inventive strategies do not assist the surgeon with the most vexing problem of interbody fusion: delivery of bone graft (BG) or BG extenders (collectively, BG) to the interbody space.