TEN BEST NEW SPINE TECHNOLOGIES FOR 2018 (Orthopedics This Week)
Winning Technology: xvision™
Inventors and Engineers: Nissan Elimelech, Stuart Wolf, Elazar Gerland, Nessi Benishti, Tsur Herman, Ziv Amitai, Ron Zaidman, Daniel Messinger, Natalie Starodubsky, Yaacov Rothschild, Asaf Asban, Nitzan Krasney, Dekel Matalon
xvision-spine system (XVS)™ is an augmented reality surgical navigation system that is designed to give surgeons a form of “X-ray vision.” Using extremely fast processing capabilities, the XVS system superimposes patient CT data, in real time, onto a heads-up display while also accurately determining the position of surgical tools real-time. The net effect is that surgeons can simultaneously look at their patient while also seeing the anatomy below and the position of instruments—without averting their eyes to a remote screen.
A recent study of using XVS in surgery found: “Overall screw placement accuracy was 96.7% and 94.6% when employing HGS and GS grading respectively. Insertion accuracy was non-inferior to MN pedicle insertion when compared to both GS and HGS scores. When compared to RN insertion, accuracy was found to be noninferior when employing the GS score, but superior when employing the HGS score. Lastly, accuracy results were found to be superior to free-hand insertion. Accuracy results were not found to be inferior in any comparison. User experience analysis yielded ‘excellent’ usability classification.”
DiFusion Technologies, Inc.
Winning Technology: ZFUZE – PEEK COMPOSITE
Inventor: Derrick Johns, Joseph Crudden, Ph.D.
Engineer: Sriram Sankar, MS
ZFUZE is a revolutionary new biomaterial. It is a blend of a base PEEK polymer and “negatively charged zeolites.” Negatively charged zeolites are specialty molecules change the surface topography, charging characteristics, and pH of the resulting implant in a manner which improves long-term patient healing. ZFUZE is NOT a COATING, or a SURFACE TREATMENT. It is, instead, an entirely new LOAD BEARING BIOMATERIAL and can be utilized across multiple orthopedic applications. ZFUZE solves the one setback PEEK had in non-osteointegration, while maintaining attractive and similar bone modulus and visualization benefits.
In two major animal studies of ZFUZE, investigators have found that the implants have “hydrophilic” surfaces which encourage early cell adhesion and osteoblast proliferation. Why? The presence of negatively charged zeolite—which resulted in reduced inflammation and fibrous tissue yet more bone”. Further, radiographic has highly indicative of “osteoconduction”. The company is seeking an osteoconduction claim with the FDA. In its bare essence DiFusion “fixed-PEEK” by adding a known hydrophilic negatively charged particle to plain old inert and hydrophobic PEEK and created a negatively charged osteoconductive biomaterial which is not recognized as a foreign body by the immune system.
Green Sun Medical
Winning Technology: Green Sun Medical Dynamic Scoliosis Brace
Inventor and Engineer: Matthew Thompson
Green Sun Medical has developed a comfortable, dynamic scoliosis brace for Adolescent Idiopathic Scoliosis (AIS). The brace applies continuous corrective pressure to the spine while allowing the patients to move and function as normal teenagers. While wearing the brace, sensor data will be transmitted through Bluetooth to mobile devices and then accessed with a cloud-based server. Physicians will be able to monitor their patients in real time to ensure that they are receiving the proper treatment. The patients will have their torso 3D scanned to allow for assembly of a custom fit ring system made from modular parts. A comfortable and breathable cover will help make the brace much less noticeable than current plastic braces.
Winning Technology: MOJAVE™ PL 3D Expandable Interbody System
Inventors: Khalid Abbed, M.D., Sabatino Bianco, M.D., Egon Doppenberg, M.D., Scott Dhupar, M.D., Gregory Lanford, M.D., Steven Ludwig, M.D., Thomas Morrison, M.D., and Brian O’Shaughnessy, M.D.
Engineers: Jennifer Moore, Jordan Floyd, and Brad Vinckier
The MOJAVE™ PL 3D Expandable Interbody System is a 3D-printed fusion device which allows surgeons to independently control anterior and posterior heights in the lumbar spine. This capability is not available with any other product on the market today.
The MOJAVE PL 3D features infinite adjustment capabilities within its expansion range – which gives surgeons the versatility to match the device to the patient’s anatomy by adjusting lordosis—up to 18 degrees. MOJAVE PL 3D’s instrumentation includes an inserter with a port for expanding and locking and an expansion driver which addresses lordosis, height, as well as posterior expansion.
The MOJAVE PL 3D Expandable Interbody System is built using an advanced 3D printing method which creates structures with greater porosity than implants fabricated using traditional manufacturing methods. Starting with a titanium powder, the MOJAVE PL 3D endplates are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and a rough surface architecture that pre-clinical data have associated with bone growth activity.
First Winning Technolgy: MoRe® (EUROPA™ Pedicle Screw System)
Inventors: Jay Yadav, M.D., Noah Roth
Engineers: Wayne Gray, Josh Gunn, Brett Cain
The EUROPA™ Pedicle Screw System is the smallest thoracolumbosacral pedicle screw system on the market yet it is two to three times stronger and four times more fatigue resistant than standard Titanium and Cobalt Chromium pedicle screw systems.
The EUROPA™ Pedicle Screw System’s polyaxial pedicle screws are made from Titanium and the rod components are made from MiRus’s novel proprietary metal alloy, Molybdenum-47.5Rhenium (MoRe®, ASTM F3273-17).
MoRe® is pure (99.99%) molybdenum and rhenium. It hydrophilic and a superiorly bio-friendly alloy. It contains no Nickel. Biomechanical and biological testing has shown that MoRe® is stronger, more fatigue resistant, less likely to generate wear debris, more osteoconductive, and biofilm resistant than Titanium and Cobalt Chromium.
Because of MoRe®, the EUROPA™ Pedicle Screw System is the world’s smallest, strongest, fatigue resistant, wear debris resistant, bio-friendly construct.
Second Winning Technology: GALILEO™ Spine Alignment System
Inventors: Jay Yadav, M.D., Angad Singh
Engineers: Angad Singh, Daniel Burnham, Alex Panter, David Harrison
The GALILEO™ Spine Alignment Monitoring System provides real-time measurement and monitoring of segmental and/or global spine alignment without repeated imaging.
The system uses disposable, miniaturized sensors and advanced sensor fusion algorithms to measure vertebral and spinal alignment in the sagittal plane. Each sensing module is battery-powered and communicates wirelessly to a tablet display.
Simulated clinical use testing using radiopaque Sawbones® and cadaver compared manual Cobb angle measurements of Lordosis and Kyphosis on lateral fluoroscopic images to the values measured by the GALILEO™ Spine Alignment Monitoring System. In benchtop testing, the mean difference between the reference values and the system measurements was 0.0 degrees with a standard deviation of 0.9 degrees (n= 90).
In simulated use testing on Sawbones®, mean difference between the cobb angle measurements and the system measurements was 1.5 degrees with a standard deviation of 1.9 degrees (n = 30). Concordance Correlation Coefficient between the two groups was calculated to be of 0.9934 (95% CI: 0.9867 to 0.9967) indicating strong agreement between system and radiographic measurements. In simulated use testing on a cadaver, mean difference between the cobb angle measurements and the system measurements was 0.3 degrees with a standard deviation of 2.6 degrees (n = 19). Concordance Correlation Coefficient between the two groups was calculated to be 0.9728 (95% CI: 0.9379 to 0.9882), again indicating strong agreement
Benchtop and simulated use testing above have demonstrated high accuracy and repeatability of the technology for real-time intra-operative monitoring of spine alignment with reduced reliance on intra-operative imaging.
Power T Handle, LLC
Winning Technology: Power T Handle
Inventors: Kevin Cahill, M.D., Ph.D.
Engineers: Steve Marinelli
The “Power T Handle” is a single-use device that allows surgeons to manually insert screws in either a traditional fashion or with power using the integrated power capabilities. The device mimics the footprint of traditional surgical instruments while also providing critical tactical feedback when desired and seamless on-demand power.
The “Power T Handle’s” power option provides surgeons with low-speed, high-torque output and requires no processing or “turnover” before or after use, including no battery recharging. It The handle works with existing orthopedic instruments including surgical taps and pedicle screw instrumentation from spinal implant manufacturers through an industry standard quick coupling connection.
Other surgical power tool options are cumbersome, require specialized adaptors, power cords and do not preserve surgeon tactile feedback during screw placement.
RTI Surgical, Inc.
Winning Technology: TETRAfuse® 3D Technology
Inventors and Engineers: Jeffrey Trudeau Michael Kakuk Stephen Horvath Katie Barron Michael Carter Brent Skaw
TETRAfuse 3D Technology is the first 3D printed polymer-based interbody fusion device to incorporate a nanoroughi surface that has demonstrated, in a pre-clinical study, more notable trabecular bone ingrowth compared to PEEK and titanium-coated PEEKii.
It is radiolucent, allowing better visualization of the implant and fusion response when compared to metal or metal-coated interbody fusion devices.ii It has bone-like mechanical properties, which help minimize potential risk for subsidence.ii Its unique nano-roughi surface exhibits decreased bacterial adhesion and growth when compared to PEEK.
TETRAfuse 3D Technology is featured in the growing Fortilink® series of devices.
Fortilink-C IBF System for anterior cervical discectomy and fusion (ACDF) surgeries.
Fortilink-TS IBF System for transforaminal lumbar interbody fusion (TLIF) or bilateral posterior lumbar interbody fusion (PLIF) surgeries.
Fortilink-L IBF System for lateral lumbar interbody fusion (LLIF) surgeries.
Simplify Medical, Inc.
Winning Technology: Simplify Cervical Artificial Disc
Inventor and Engineer: Yves Arramon, Ph.D.
Simplify Disc is a three-piece, non-metallic cervical artificial disc comprised of Polyetheretherketone (PEEK) endplates with a ceramic core.
Simplify Disc is designed to be MRI-compatible, including minimal artifact, thereby reducing or eliminating the need for future CT scans and the risks associated with ionizing radiation.
The PEEK-on-ceramic materials of the Simplify Disc were chosen for enhanced durability and lower wear rates, with no metal wear from the articulations. The bone-contacting surface of each endplate is coated with biocompatible porous titanium to promote stable bony ongrowth.
The Simplify Disc is designed to mimic the natural motion of the spine. The disc is designed for maximum range of motion without anatomic constraint: ±12° flexion/extension, ±12° lateral bending, unlimited axial rotation, and a limited amount (<1.6 mm) of translation in the horizontal plane.
The ceramic core is semi-constrained by the retention ring, allowing for a self-centering mobile core. Simplify Disc has variable center of rotation which mimics the natural motion of the spine. The heights of the Simplify Disc range from 4mm to 6mm to match the anatomical size of native discs. The Simplify Disc has completed enrollment of the 1-level FDA Clinical Trial and anticipates enrollment of the 2level FDA Clinical Trial by the end of 2018.
Winning Technology: Alara Access Needle
Inventors and Engineers: Travis Greenhalgh, Andrew Shoup
The ALARA system is an inexpensive solution to provide radiation reduction to the surgeon which any surgeon, hospital or ASC can afford or have access to.
The system allows the surgeon to navigate the correct trajectory quickly to save time in the operating room.
The ALARA Target Needle has a built-in depth stop and neuromonitoring capabilities which helps ensure safe placement of pedicle screws.
The ALARA extension arm allows the surgeon to maintain a safe distance to decrease radiation exposure significantly while finding the right trajectory while placing a needle. The handle is durable, rigid and can be disposable.
Tyber Medical LLC
Winning Technology: ProTi 360 (TyPEEK) Interbody Systems
Inventors: Jeff Tyber
Engineers: Matt Atoulikian, Chandler Kline, Chris Faresich, Dan Hickey, Ph.D., Bess Lorman, Gary Thomas, Tom Fosberner, Jeff Tyber, Mike Black, David Gerber, Kristin Jinx
The Tyber Medical TyPEEK Interbody System is a spinal fusion interbody device comprised of a poly-etherether-ketone (PEEK) core surrounded on all exterior-facing surfaces by an integrated titanium surface layer designed to enhance primary implant stability and stimulate accelerated osseointegration.
The 360° integrated titanium surface layer is applied using a proprietary substrate preparation treatment that primes the PEEK surface to interlock on a mechanical and molecular basis with a modified titanium plasma spray coating, resulting in unparalleled bond strength.
This novel coating approach creates hierarchical surface roughness with features extending from the macroscale to the nanoscale, providing increased surface area for the attachment of proteins/cells and stimulating enhanced osteogenic activity from adhering cells to promote direct bony on-growth.
The Tyber Medical TyPEEK Interbody System combines the radiolucency and desirable mechanical properties of a PEEK core with the roughness and osteogenic activity of a 360° integrated titanium surface layer to deliver an optimized interbody spacer that promotes rapid and long-lasting fusion across the entirety of the implant.
CONGRATULATIONS to all of our winners for 2018!
Rewarding Innovation and Perspiration
This 2018 annual award rewards inventors, engineering teams, surgeons and their companies who’ve created the most innovative, enduring and practical products to treat back care. To win the Orthopedics This Week Best New Technology Award for spine care, a new technology must meet the judges’ following criteria:
- Be creative and innovative.
- Have long term significance to the problem of treating the diseases of the spine. Does this technology have staying power?
- Solve a clinical problem. To what extent does this technology solve a current clinical problem or problem that is inadequately solved today?
- Does it have the potential to improve standard of care?
- Is it cost effective?
- I would use it.
Our expert panel scores every submission on a scale of 1 to 5 (5 being the highest score) for each of the above criteria.
We and our panelists were impressed that inventors—despite ever growing hurdles to innovation and entrepreneurism in spine—still managed to create a solid group of new products to submit for the 2018 Orthopedics This Week Spine Technology Awards.
A record 31 companies submitted their best ideas for the 2018 BEST SPINE TECHNOLOGY award. We offer our thanks and deep appreciation to the engineering teams, surgeon inventors and the following companies for submitting their best ideas this year.
Our intrepid panel of eight judges were:
Paul A. Anderson, M.D.: Dr. Anderson is professor at the University of Wisconsin School of Medicine and Public Health and nationally recognized expert in spinal trauma and complex cervical spine disorders. His research encompasses spinal fixation implants, the artificial cervical disc and basic research in disc regeneration. His current projects include: Sleep Disturbance in Orthopedic Patients Continuous Motion Analysis of the Human Spine and a Classification System for Lumbar Degenerative Disc Disease
Scott Boden, M.D.: Chairman of the Department of Orthopaedics, Director of Emory Orthopaedics & Spine Center and Chief Medical Officer Emory University Orthopaedics & Spine Hospital, Dr. Scott Boden is one of the founding fathers of modern spine surgery. He is an internationally renowned lecturer and teacher and is one of the world’s top spine surgeons and researchers.
Dr. Boden’s research currently encompasses cell/molecular biology of osteoblast differentiation including study of the mechanism of action of bone growth factors (BMPs), the design and development of small drug-like molecules that will enhance bone formation locally, regionally, and possibly systemically, animal models of spine fusion to understand the biology of the healing process and test the efficacy of various bone graft substitutes and outcomes research relating to spinal disorders, diagnostic imaging, and utilization of health care resources.
Boyle Cheng, Ph.D.: Dr. Cheng is Professor of Neurosurgery at Drexel University – Allegheny General Hospital. He is the Director of Research for the Neuroscience Institute at Allegheny Health Network and maintains an adjunct appointment in the Department of Biomedical Engineering at Carnegie Mellon University. His grant-funded research has included topics including the evaluation of anterior cervical disc replacement in a sheep model, biomechanical studies of a biased angle posterior cervical system, facet motion preservation technologies as well as dynamic and physical modeling based on specimen specific imaging and kinematic studies.
Reginald Davis, M.D., FACS: Dr. Davis is the Director of Clinical Research at the Laser Spine Institute. He first made his mark as part of the elite medical team that performed the 22-hour, historic surgery to successfully separate conjoined twins at the Johns Hopkins Hospital. Today Dr. Davis is one of the most published spine researchers and most recently brought his thoughtful, methodical approach to identifying, evaluating and implementing new technologies in the ambulatory spine surgery setting. Dr. Davis is active in numerous professional societies including the Florida Neurosurgical Society and the American Board of Neurological Surgery.
Ira L. Fedder, M.D.: Dr. Fedder is a fellowship-trained orthopaedic surgeon with Towson Orthopaedic Associates in Maryland. Dr. Fedder is experienced in all aspects of spine and neck problems including the treatment of arm pain, cervical disc herniations, myelopathy, cervical stenosis, leg pain and weakness, lumbar stenosis, sciatica, lumbar disc herniations, tumors, and infections. He is also author and co-author in dozens of clinical studies, a consultant to young technology companies and a frequent presenter at surgeon meetings.
Jeffrey A. Goldstein, M.D.: Dr. Goldstein is the chief of the Spine Service for Education and program director of the Spine Fellowship in the Department of Orthopedic Surgery at NYU Langone. Dr. Goldstein is a particularly active researcher in the areas of biomedical materials and devices and participates regularly in clinical trials. Dr. Goldstein is also the author of numerous book chapters and articles that have been published nationally and internationally. He is the winner of the Leon L. Wiltse “Best Paper” award at the annual meeting of the International Society for the Advancement of Spine Surgery. He was selected by New York Magazine and Super Doctors as one of New York’s “Best Doctors” and by Castle Connolly as one of America’s “Top Doctors.” Finally, Dr. Goldstein serves on the editorial and advisory boards of The Spine Journal, the International Journal of Spine Surgery, the Global Spine Journal, Spine Surgery Today, and the Bulletin of the Hospital for Joint Diseases, and is on the review board for Spine.
Scott Webb, D.O.: Dr. Webb is Surgical Director of Florida Spine Institute and participates in several research projects including motion preservation and minimally invasive surgical techniques for the treatment of spinal stenosis and back or neck pain. Dr. Webb performed the first Facet Joint Replacement in the Lumbar Spine in both Romania and in the United States. He received his Honorary Doctorate (Honoris Causa) from Victor Babes University of Medicine. He is a member of the North American Spine Society, American College of Spine Surgeons, American Osteopathic Association, American Osteopathic Academy of Orthopedic Surgeons, and American Academy of Orthopedic Surgeons.
Hansen A. Yuan, M.D.: Dr. Hansen A. Yuan is the retired Professor of Orthopaedic and Neurological Surgery at the State University of New York Upstate Medical University. Dr. Yuan has trained thousands of surgeons from around the world and has advised hundreds of young medical technology firms. Dr. Yuan has authored more than 100 articles and many abstracts published in peer-reviewed journals. He has been a contributing author of 16 chapters to medical books. Dr. Yuan researches in the areas of degenerative disc disease, scoliosis, and bone healing and bone substitute. In North America and Asia, universities and hospitals invite Dr. Yuan as a visiting professor. Many times, he has been a Presidential Guest to the Republic of China speaking on Orthopaedic Surgery.