THE Best New Spine Technologies for 2021
The companies with the BEST new spine care technologies for 2021 are: Carlsmed, Inc., Centinel Spine, DisCure Medical, Dymicron, Globus Medical, Inc., icotec Medical, Misonix, Inc., PrecisionOS Technology, Sectra AB, TheraCell, Inc.
CONGRATULATIONS to all of our winners for 2021!
Rewarding Innovation and Perspiration
This annual award rewards inventors, engineering teams, surgeons and their companies who have created the most innovative, enduring, and practical products in 2021 to treat back care. To win the Orthopedics This Week Best New Technology Award for spine care, a new technology must meet the following criteria:
- Be creative and innovative.
- Bring long term significance to treating spine pathologies. Does this technology have staying power?
- Solve a current clinical problem.
- Improve standard of care
- Is 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.
A record number of technologies were submitted for the 2021 BEST SPINE TECHNOLOGY award. We offer our thanks and deep appreciation to the engineering teams, surgeon inventors and companies for submitting their best ideas this year.
Paul Anderson M.D.: Dr. Anderson is a nationally recognized expert in spinal trauma and complex cervical spine disorders. His research specialties include spinal fixation implants and the development of an artificial cervical disc. Dr. Anderson's research specialties include spinal fixation implants, the development of an artificial cervical disc, and basic research in disc regeneration. His current projects include Sleep Disturbance in Orthopedic Patients. The purpose of the research is to find out if the type of orthopedic problem a person has (spine, shoulder, hip, or knee) affects their sleep, Continuous Motion Analysis of the Human Spine and Classification System for Lumbar Degenerative Disc Disease.
Scott Blumenthal, M.D.: Dr. Blumenthal is a spine surgeon with the Texas Back Institute and the first and only surgeon in the United States to devote his practice solely to the research and application of artificial disc replacement. Dr. Blumenthal was instrumental in bringing artificial disc replacement surgery to the United States. Dr. Blumenthal graduated from Northwestern Medical School in Chicago. His general surgery internship and orthopedic surgery residency was at the University of Texas Health Science Center. He is clinical assistant professor of orthopedic surgery at the University of Texas Southwestern in Dallas and is an ongoing contributor to the first non-profit foundation created for arthroplasty patients.
Peter Derman, M.D.: Dr. Derman, a minimally invasive and endoscopic spine surgeon at Texas Back Institute, graduated with honors from Stanford University after completing a Bachelor of Science in Biological Sciences. His medical degree is from the Perelman School of Medicine at the University of Pennsylvania. He also holds an MBA from the Wharton School of Business. Dr. Derman’s residency was at the Hospital for Special Surgery in New York. Dr. Derman completed his Fellowship in Spine Surgery from Rush University Medical Center in Chicago, Illinois. In his personal time, Dr. Derman enjoys staying fit, sailing and brewing craft beer with his wife.
Vijay Goel, Ph.D.: Dr. Goel is the Distinguished University Professor and McMaster-Gardner Endowed Professor in Orthopedic Bioengineering at the University of Toledo. He is co-director for Center for Disruptive Musculoskeletal Innovations (CDMI) and is known worldwide for his pioneering research in the field of spinal disorders with multiple publications and peer-recognitions, including four life-time achievement awards from four professional societies. Dr. Goel has licensed four of his concepts to companies and carries out various FDA-required testing for most multinational and start-up companies. Dr. Goel was the founding Co-Chair of the ASTM Committee on Spinal Implants and laid the foundation for developing the guidelines for implant evaluation.
Douglas Orr, M.D.: Dr. Orr is a staff physician at the Center for Spine Health and the Department of Orthopaedic Surgery on Cleveland Clinic’s campus. Dr. Orr's interests include adult spinal surgery, minimally invasive surgery and deformity surgery. His research focuses on spinal surgery outcomes, spinal biomechanics and biomaterials. Dr. Orr came to Cleveland Clinic from Ontario’s Hamilton Health Sciences Corporation, where he served as chief of orthopaedics, Division of Orthopaedic Surgery. Dr. Orr also served as the assistant clinical professor of surgery. He has received numerous awards, including the Silver Hip Award for Best Teacher awarded by the residents of McMaster University Orthopaedic Program and the Robin Sullivan Award for Excellence in Orthopaedic Research from University of Toronto Orthopaedic Research Day. He has authored numerous publications and presentations for medical journals and conferences.
So, without further delay, here are the ten best new spine technologies for 2021 in alphabetical order.
Top Ten Spine Technologies for 2021
Winning Technology: aprevo™
Inventors and Engineers: Mike Cordonnier and Niall Casey
Technology Description: aprevo is the first digital-to-device patient specific interbody technology for treating adult spinal deformity (ASD). Using patient imaging data, the system creates surgeon-specific and patient-specific surgical plans, and manufactures personalized 3D printed spinal devices to achieve each plan. Each titanium aprevo device is highly individualized by size, shape, lordotic and coronal angles, and height. The system also provides an anatomical interface that matches the patient’s vertebral endplate topology. The aprevo devices may be implanted via an anterior, lateral or transforaminal approach. Data is uploaded via a secure user interface and within weeks of plan approval, a sterile kit with personalized implants and an implant inserter are delivered to the OR. No need for the costly reprocessing of traditional stock implants. FDA awarded aprevo Breakthrough Technology status since it provides more effective ASD treatment than standard of care—the first ever in spine or orthopedics. Centers for Medicare and Medicaid Services (CMS) awarded aprevo the highest ever New Technology Add-on Payment (NTAP) in spine or orthopedics, up to $40,950, beginning October 2021, and a Transitional Pass-Through (TPT) for outpatient procedures.
No need for the costly reprocessing of traditional stock implants. FDA awarded aprevo Breakthrough Technology status since it provides more effective ASD treatment than standard of care—the first and only in spine or orthopedics. CMS awarded aprevo New Technology X-codes and a 65% New Technology Add-on Payment (NTAP) beginning October 2021.
Centinel Spine LLC
Winning Technology: prodisc L Inferior Angled Endplates
Inventor: Dr. Thierry Marnay
Engineer: Ed McShane
Technology Description: These unique endplates are designed to shift the lordotic angle of the prodisc L implant to the inferior endplate, expanding the options available to surgeons to better address the varied lumbar anatomy and pathology of patients. With these inferior Angled Endplates, the operative level is horizontalized, reducing the sacral slope and minimizing shear forces on the implant. The angle in the inferior plate also elevates the lumbosacral joint higher within the pelvis, optimizing lateral bending and axial rotation, which may improve overall motion at L5-S1 and L4-L5. The manufacturer, Centinel Spine, has released six angled options, including inferior endplates with lordotic angles of 3° and 8° and a superior endplate with a lordotic angle of 3°. The prodisc L system remains the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine and these inferior Angled Endplates are now offered for both international and U.S. surgeons' use.
Winning Technology: DisCure System
Inventors and Engineers: Yossi Gross, Yuval Mandelbaum, Yehuda Zadok
Technology Description: The DisCure system is a miniature, fully implantable pulse generator (IPG) to treat early to mid-stage degenerative disc disease (DDD), reversing the degenerative process and restoring the disc's healthy function. DisCure is implanted in a minimally invasive procedure, under local anesthesia. The system restores the natural negative charge and electric gradient in the disc, restoring the inflow of fluid, oxygen, and nutrients into the nucleus, improving environmental conditions for disc-cells; increases disc volume and improves fluid exchange—flushing out metabolism byproducts, acid, MMPs and cytokines. In DDD, degenerative changes cause the pumping function to fail, and cells undergo apoptosis and ECM, and GAG levels diminish. Reduction in proteoglycans and GAGs reduces the natural negative charge in the disc and further diminishes the healthy pump function, leading to ultimate drying and collapse of the disc. The system restores the negative charge by delivering electrical pulses to the disc. DisCure is being evaluated by the FDA under its Breakthrough Device Designation.
Winning Technology: Triadyme® - C Cervical Artificial Disc
Inventors: Bill Pope, Ph.D. and Bao-Khang Nguyen, Ph.D.
Engineers: Jeffery Taylor, M.D., David Harding, Ph.D., Steven Ulmer, Dean Blackburn, Eric Lange
Technology Description: Triadyme-C is a next generation artificial cervical disc which utilizes a proprietary polycrystalline diamond material, and a patented Tri-Lobe articulating design to emulate the complex coupled motion of a natural spinal disc while providing stability throughout the range of motion. The exceptional durability of polycrystalline diamond virtually eliminates the risks of long-term wear debris. Polycrystalline Diamond is a sintered monobloc of diamond microcrystals that have been fused together at a pressure of 1 million pounds per square inch and a temperature of 2,700° Fahrenheit. The material is fully compatible with X-ray and CT diagnostics, and MRI-compatible with little artifact, allowing clear images at the treatment level.
The novel Tri-Lobe articulating mechanism design replicates the natural motion of the spine while being both energetically stable and aligning both the axis of load and the center of rotation. Three spherical lobes mate with three non-congruent, spherical pockets which makes Triadyme-C a self-centering device, allowing motion in a variety of axes. These physiological characteristics are very similar to those of the natural spinal disc—and they can’t be achieved with the ball-and-socket joint used in current devices.
Globus Medical, Inc.
Winning Technology: Excelsius 3D™
Inventors: Norbert Johnson, Robert Stevens, Yuan Cheng, Hisham Salem
Engineers: Matthew McGowen, Kevin Zhang, Caroline Conrad, Loga Natarajan, Bharat Mathur, Joseph Mulligan, Douglas Legere, James Yau, Michael Norcia, Steve Tracy, Robert LeBoeuf, David Cleary, Alex Krull, Saumya Shah
Technology Description: Excelsius3D is a 3-in-1 imaging platform with cone-beam CT, fluoroscopy, and digital radiography consolidated into one adaptable unit. Smart features—such as base and gantry position memory for a simple return to various positions, omnidirectional wheels that glide seamlessly along the floor in any direction, and advanced collimation techniques in all three imaging modalities—expedite imaging setup, fine-tuning, and acquisition. The system’s inner and outer Cs rotate independently for a full 360o spin. The compact footprint and elimination of a separate viewing station, along with the haptic-touch handle and handheld controller’s three joysticks, simplify system transport and allow precise motion and positioning. Integrated navigation arrays accelerate registration with ExcelsiusGPS® and ExcelsiusHub™ for all three navigation workflows.
icotec Medical, Inc.
Winning Technology: Cervical Plate icotec
Technology Description: icotec’s Anterior Cervical Plate is manufactured from BlackArmor®, a material created from carbon-fiber-reinforced polyetheretherketone (PEEK) using icotec’s unique Composite Flow Molding (CFM) process. The result is an implant with the radiolucency of PEEK and the strength of carbon-fiber, allowing the implant to withstand the mechanical demands and stresses of anterior cervical stabilization while still providing the visibility needed for tumor treatment. The outstanding structural integrity is due to the interwoven, uncut, 3D fiber architecture, making it comparable in rigidity and strength to a standard titanium metal implant. BlackArmor Cervical Plate is truly one of kind due to its radiolucency on X-ray, CT, and MRI. Small tantalum markers embedded in the tips and heads of the screws to help with visibility on intra-operative and post-operative imaging. The icotec Anterior Cervical Plate implants are available from 1 to 4 segments, ranging in length from 21 - 94mm; all options are 18mm in width. Additionally, Cervical Plate options are designed to match the natural lordosis of the spine, they come prelordosed ranging from 6° and 22°. The self-tapping screws are available in diameters of 4.0mm and 4.25mm, with lengths of 13mm and 15 mm, and have fully threaded conical heads designed to block pullout by firmly locking into the plate. Further, the fixed cranial screw angulation prevents penetration through the lower endplate of the vertebral body.
Winning Technology: PrepFx Powered by neXus; Ultrasonic Disc Preparation
Inventors and Engineers: Dr. Nicholas Theodore, Dan Voic, Paul Mikus, Christopher Ballor, Alex Darian
Technology Description: Misonix’ neXus Ultrasonic Interbody & Fusion Preparation (UIFP) Solution is an ultrasonic surgical aspiration system leveraging small mechanical vibrations, in conjunction with cavitation, to provide clinicians an ALL-IN-SOLUTION capable of accessing a desirable pathology, removing a defect, and ensuring adequate closure/sealing of the disc space. Technology for disc herniations in spine surgery has failed to provide a single solution capable of addressing all aspects of discectomy including accessing the herniation, removing disc material, and sealing the disc. Until the launch of the Ultrasonic Microdiscectomy solution powered by SonaStar on neXus, a microdiscectomy has been a complicated procedure requiring multiple instruments/devices leveraging various technologies. The UIFP Solution allows for hard tissue management (e.g., bone, disc material, endplate, etc.) and simplifies the complex workflow of one of the most common spinal decompression applications, and to do so with a single device.
Winning Technology: Multiuser virtual surgical training and education for scoliosis
Inventor and Engineer: Nhu Nguyen, Frank Lueck, Simon van de Lagemaat, Kevin Chorney, Colin O’Connor, Cale Werake, Thoufeeq Ahmed, Marie Lamouret, Rob Oliveira and Danny Goel, M.D.
Technology Description: PrecisionOS is the developer of a novel virtual technology which uniquely combines critical decision making with technical skills training to improve surgeon expertise. This software provides surgical and skills training incorporating all the steps of surgery in case-based scenarios with real time feedback in order to achieve surgical competency. The training occurs in a high-fidelity virtual reality (VR), fully immersive environment which truly simulates the real operating room. Surgeons and trainees normally practice on patients to improve their skill. The surrogate to this is saw bones and cadavers. Both these options are expensive, inconvenient, and provide no feedback on performance and no relevance to the trainees’ desire to objectively improve their skills. VR is cost-effective and can be employed to educate surgeons globally with collaborative sessions. New surgical technologies tend to require steep learning curves and can deter people from learning new skills (especially if the previous method of completing surgeries is also very successful). Providing a platform for faster and more efficient learning will be beneficial for new surgeons on the global scale—including remote areas which can be difficult to physically reach or areas in the world where there is not a large concentration of orthopedic surgeons.
Winning Technology: SECTRA IMA®
Inventors and Engineers: Per Svedmark, Henrik Olivecrona, Stefan Lindholm, Anders Hedblom, David Rundqvist, Olof Sandberg, Rolf Scheiderbauer
Technology Description: Sectra’s IMA technology is meant to detect post-operative implant loosening in patients who present with pain. It is a noninvasive imaging technology which enables a clinician to see and precisely quantify the primary signs (i.e., the actual in vivo movement) of pseudoarthrosis and/or implant loosening. This greatly reduces ambiguity in these sometimes quite challenging and vital diagnostic situations. IMA is applicable to both lumbar and cervical spine patients. IMA is based on acquiring two CT scans of a patient in between which the patient changes position. This position change, extension and flexion, induces a difference in loading over the relevant segment of the spine. Thereafter IMA, through image processing algorithms, overlays a particular vertebrae or implant in the two scans. This enables the clinician to jump between the exact same slice and position in both scans and provides a direct visual high precision impression of any loading induced movement. IMA also allows for precise quantification of the size of the movement, in millimeters and degrees, in all 3-cardinal axis. The technology is low dose compatible.
Winning Technology: TheraFuze DBF® Fiber Anchor™
Inventors and Engineers: Andrew Carter, Ph.D., Nelson Scarborough, Ph.D., Bradley Patt, Ph.D., Ian McRury, Ph.D.
Technology Description: The TheraFuze DBF Fiber Anchor is a novel product that acts much like a drywall anchor, but for use in orthopedics and specifically in pedicle screw fixation in spine. It is intended to provide immediate improvement for screw fixation in primary surgeries and revision cases. The Fiber Anchor is a biological implant that is osteoconductive and osteoinductive which benefits long term healing. It is molded from 100% demineralized cortical bone fibers generated with the company’s patented manufacturing processes yielding long and strong fibers that have the natural nanotopography of the bone preserved. Design inputs to the Fiber Anchor included a tapered shape to ease insertion, a screw centering design, and a proximal flare to resist downward migration during insertion. Testing has demonstrated that the Fiber Anchor more than doubles the pullout force versus screws implanted without the Fiber Anchor. Histological evaluation in a sheep model confirmed new bone formation at 4 weeks and progression of bone remodeling in apposition to the screw and the edge of the defect at 12 weeks. The Fiber Anchors are being used clinically now, and a cannulated version for placement over a guide wire is in development.