VA Hospitals Can Now Order Kleiner KG1 Bone Graft Tool Through GSA To Improve Spinal Fusion Success Rates

PRESS RELEASE

FOR IMMEDIATE RELEASE 

VA Hospitals Can Now Order Kleiner KG1 Bone Graft Tool Through GSA To Improve Spinal Fusion Success Rates

Incline Village, Nev., June 18, 2019 – Kleiner Device Labs today announced final approval by the Department of Veterans Affairs (VA) for making the Kleiner KG1 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, number 36F79719D0049, directly or on GSA Advantage.

In its peer-reviewed published clinical testing, the KG1 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 KG1 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 KG1 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.

 About the KG1

The Kleiner Device Labs KG1 represents a significant improvement in graft delivery for TLIF and lateral spinal fusion procedures, as well as sacroiliac fusions.  It features a rectangular cannula with a wedge tip and bi-portal graft extrusion zones as well as a removable funnel. Unlike round, end-dispensing devices, it leaves a natural void for fusion cage placement.

About Government Marketing and Procurement, LLC

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. With 20 years’ experience and $200M of contracting success, GMP improves government performance, productivity, and financial stewardship www.gmpgov.com.

About Kleiner Device Labs

Kleiner Device Labs is creating new tools to advance minimally invasive spine surgery and improve outcomes and costs for patients, surgeons, hospitals and payers.
http://www.kleinerlabs.com/

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

Media and Investor Contacts

Kleiner Device Labs
Brad Samson
brad.samson@kleinerlabs.com
c: 714.955.3951

Government Marketing and Procurement, LLC
Laiken Kuykendall
lkuykendall@gmpgov.com
571.577.7272

The Medical Center of Aurora: Pioneering Spine Surgery

PRESS RELEASE

FOR IMMEDIATE RELEASE 

The Medical Center of Aurora: Pioneering Spine Surgery
Increasing Patient Safety Outcomes

Aurora, Colorado – June 28, 2018 –The Medical Center of Aurora (TMCA) is among the first hospitals in Colorado to begin using a new bone graft tool to achieve better patient outcomes in spinal fusions. TMCA spine surgeon, Stephen Pehler, MD, is conducting minimally invasive spinal fusion procedures using the new device and in the process increasing patient success rates for spinal fusions from the national average of 75% to 92%.

Jeffrey Kleiner, MD, developed the KG1 bone graft tool while performing surgeries at The Medical Center of Aurora. The tool is a solution to spine surgeons’ frustrations over delivering bone graft material during spinal fusion procedures. The device benefits patients by limiting the amount of retraction of their sensitive nerve tissue and allowing surgeons to fill their disk space with bone graft in one pass. This process greatly increases the success of the operation and reduces the potential of requiring another surgery. 

The KG1 is a disposable device and will positively impact the outcome of patients needing a lumbar spinal fusion due to degenerative disc diseases, arthritis in the back and back injuries. 

The Medical Center of Aurora’s President & CEO, Dan Miller, said, “We are pleased to offer this device as an option for use in our lumbar spinal fusion surgeries. At TMCA we continually focus on ways to improve patient outcomes and provide better patient care, and this new bone graft tool allows us to do this.”

According to Dr. Pehler, “The Kleiner bone graft funnel assists my surgical cases and practice in several ways. Not only has it increased our documented fusion rates in patients from both a minimally invasive and open TLIF approach, it also greatly improves optimal bone graft delivery efficiency and safety.” Pehler continued, “The funnel allows for stable and safe direct delivery of bone graft into the disc space without the need for nerve root and dural retraction. Eliminating repeated graft delivery near the dura and nerve elements through conventional means, this device greatly improves efficiency and safety for our patients.”

About The Medical Center of Aurora

The Medical Center of Aurora, the first community hospital in the Denver Metro area to receive two-time Magnet designation for nursing excellence by the American Nurses Credentialing Center (ANCC), is a 346-bed acute care hospital located in Aurora, Colorado. The Medical Center of Aurora is comprised of six campuses in Aurora and Centennial, Colo., including the South Campus, located at Interstate 225 and Mississippi, the North Campus Behavioral Health and Wellness CenterCentennial Medical Plaza, Saddle Rock ER, Spalding Rehabilitation Hospital, Spalding Rehabilitation at P/SL, and a medical office building at Green Valley Ranch. The South Campus facility is a Level II Trauma Center with Primary Stroke Certification and Chest Pain Center accreditation, and has an affiliation with Rocky Mountain Hospital for Children. The Medical Center of Aurora received ‘A’ grades from The Leapfrog Group (Fall 2015, Fall 2016, Spring 2017, Fall 2017, Spring 2018), was Colorado’s only hospital to receive the Leapfrog Top General Hospital designation two years in a row (2016, 2017), and was recognized as the #4 hospital in the Denver metro area and the #4 hospital in Colorado by U.S. News & World Report (2014-2015, 2017-2018). The Medical Center of Aurora and its affiliated campuses are part of the HealthONE System. Learn more at www.AuroraMed.com

 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 www.kleinerlabs.com.

KG is a registered trademark of Kleiner Device Labs/Spinal Surgical Strategies

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