THE Best New Spine Technologies for 2020 | Orthopedics This Week

THE Best New Spine Technologies for 2020

RRY Publications LLC ©

The companies with the BEST new spine care technologies for 2020 are:

Auctus Surgical, Inc., Camber Spine Technologies, LLC, Centinel Spine, LLC, Circinus Medical Technology, LLC, DuraStat, LLC, Fusion Robotics, LLC, Kuros Biosciences AG, Molecular Surface Technologies, SurGenTec, Woven Orthopedic  Technologies, LLC.

CONGRATULATIONS to all of our winners for 2020!

Rewarding Innovation and Perspiration

This annual award rewards inventors, engineering teams, surgeons and their companies who’ve created the most innovative, enduring and practical products in 2020 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:

  1. Be creative and innovative.
  2. Bring long term significance to treating spine pathologies. Does this technology have staying power?
  3. Solve a current clinical problem.
  4. Improve standard of care
  5. Is cost effective
  6. 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 for the 2020 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.

The Judges

(Top Row): Paul Anderson, M.D.; Jeffrey A. Goldstein, M.D.; Jeffrey L. Gum, M.D. (Bottom Row): Mark Reiley, M.D.; Kern Singh, M.D.; Hansen Yuan, M.D.

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—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.

Jeffrey A. Goldstein, M.D.:  Dr. Goldstein is the Chief of the Spine Service and an orthopedic spine surgeon at NYU Langone Orthopedic Hospital. Dr. Goldstein is nationally and internationally recognized for his expertise in minimally invasive spine surgery, robotic spine surgery, and artificial disc replacement. Dr. Goldstein also serves as clinical professor of orthopedic surgery and neurosurgery at NYU Grossman School of Medicine. He is also director of NYU’s spine fellowship program. His research interests include biomedical materials and devices, as well as several clinical trials. Finally, Dr. Goldstein is the author of numerous research studies, book chapters and articles that have been published nationally and internationally.

Jeffrey L. Gum, M.D.:  Adult and Pediatric Spine Surgeon at the Norton Leatherman Spine Center in Louisville, KY, Assistant Clinical Professor University of Louisville Department of Orthopaedic Surgery, winner of NASS-Spineline’s Top 20 Spine Surgeon under 40 award in 2019, 2016 NASS Value Abstract Award for his paper regarding the cost-effectiveness of circumferential fusion for lumbar spondylolisthesis which compared TLIF and Antero-Posterior Fusion. Dr. Gum has authored numerous research studies, books chapters and articles published nationally and internationally.

Mark Reiley, M.D.:  Mark Reiley is a retired orthopedic surgeon who is probably best known for his Kyphoplasty invention and iFuse. Over this remarkable career, Dr. Reiley has invented a series of implants, instruments and procedures which have both improved patient care and prompted the founding of seven orthopedic device companies, most recently Si-BONE, Inc. Over his career as a surgeon, Dr. Reiley filed for and was issued more than 200 medical device patents. In 2008, Dr. Reiley was awarded the Phoenix Lifetime Achievement in Medicine.

Kern Singh, M.D.: Dr. Singh is the Professor in the Department of Orthopaedic Surgery at Rush University Medical Center and is co-director Minimally Invasive Spine Institute and Endoscopic Spine Surgeon. Dr. Singh is an internationally recognized expert in minimally invasive spinal surgery. He also contributes extensively to creating innovative designs for MIS spinal instrumentation and is one of the few surgeons in the United States performing endoscopic spine surgery. Dr. Singh also specializes in the minimally invasive treatment of spinal tumors and adult spinal deformities.

Hansen Yuan, M.D.: Dr. Yuan is the retired Professor of Orthopaedic and Neurological Surgery at the State University of New York (SUNY) Upstate Medical University. He is generally recognized the Dean of modern spine surgery having served as President of literally every major spine surgeon society. Dr. Yuan earned his medical degree from the University of Michigan Medical School and was in a post-graduate Fellowship with the legendary Dr. Leon Wiltse. Dr. Yuan also served in the United States Army for a total of six years. Dr. Yuan has authored several hundred articles, abstracts and medical textbook chapters. During his long and distinguished career, Dr. Yuan devoted himself to advancing the treatment of degenerative disc disease, scoliosis, and bone healing and the use of bone substitutes. Dr. Yuan has been a visiting professor at major academic institutions in North America and Asia.

So, without further delay, here are the ten best new spine technologies for 2020 in alphabetical order.

Top Ten Spine Technologies for 2020

Auctus Surgical, Inc.:  Dynamic Vertebral Body Tethering System™

Inventors and Engineers:  John Barrett, Murali Kadaba, Ph.D., Dillon Kwiat

Technology Description:  The Auctus Dynamic Vertebral body Tethering System (VBT) is a non-fusion treatment for pediatric patients (usually 8-12 years old) who have a severe enough spinal curve (cobb > 40 degrees) to warrant surgery. The non-fusion procedure uses a flexible tether made of a high molecular weight polyethylene material (Dyneema) to constrain one side of the spine. As a child grows, the unconstrained side of the spine “catches up” to the convex side, straightening the curve. This principle is called Growth Modulation.

The tether is affixed surgically via bone screws to the lateral side of each vertebra on the convex side of the curved portion of the spine. The tether is anchored at the top and bottom of the construct. The tether moved freely through the middle screws.

The Auctus system is adjustable using a magnetic tensioning system. The tether, which is anchored at one end, but attached to a spool at the other end which is actuated by an external magnetic controller. The tether may be tensioned over time. Once the spine is straight, tension can be released, guarding against over-correction.

Camber Spine Technologies, LLC:  OLIF Retractor SystemTM with Blade to Blade Safe TechnologyTM

Inventor:  John Williams, M.D., Seth Anderson

Engineer:  Megan Stauffer, Jason Cianfrani

Technology Description:  The Camber Spine OLIF System consists of implants, a modular retractor system, bent disc prep instrumentation, and an articulating inserter specifically designed for the oblique lateral interbody fusion (OLIF) approach. The Camber Spine OLIF implants are designed for an oblique approach (25° from true lateral) and do not require the use of an orthogonal maneuver to properly align the lordosis of the implant. The OLIF Retractor System consists of handheld blades that can be rigidly fixed to the table or to other blades using a series of mini arms. The articulating inserter allows for the in situ adjustment of the inserter handle angle for precise implant insertion.

Centinel Spine, LLC:  prodisc L Total Disc Replacement™ Two-Level

Inventors and Engineers:  Many engineers, inventors and physicians contributed to the development of the prodisc-L. Of special note are Dr. Rudolf Bertagnoli, who is Department Head of Spine at three hospitals in Germany and critical to the early development of prodisc-L and then Jack Zigler, M.D., from the Texas Back Institute in Plano, Texas, who performed the first prodisc-L lumbar ADR surgery in the United States.

Centinel Spine received FDA approval for two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR) System on April 10, 2020, becoming the only company with a lumbar TDR device that has been clinically reviewed and found safe and effective for two-level use by the FDA.

Although the approval is very recent, prodisc L was first implanted in the United States during concurrent investigational device exemption (IDE) studies to obtain FDA approval for one- and two-level use. The first two-level implantation in the U.S. took place on January 22, 2002 by Jack Zigler, M.D. at the Texas Back Institute. Results from the study have been published in numerous peer-reviewed journal articles, presented at plentiful national and international conferences, and are part of the over 540 published studies on the prodisc technology platform. More than 30 peer-reviewed articles have been published on results of two-level prodisc L clinical use with up to 13 years follow up, supporting the newly approved indication for prodisc L with many years of positive patient results.

The two-level FDA PMA (premarket approval) development and submission by Centinel Spine exemplifies the dedication to expanding care to patients with two-level lumbar disc degenerative disease. The PMA approval is a win for many patients across the U.S. who now have an alternative to fusion for their two-level disease.

Circinus Medical Technology, LLC.:  bolt Spine Navigation System

Inventor:  John K. Dorman, M.D.

Technology Description:  Circinus offers a remarkably accurate, easy to use, low-cost, and safe spine navigation solution. The system utilizes an iPod touch, with its A10 fusion chip, 8MP camera, and highly sensitive gyroscope, to efficiently and effectively guide the placement of pedicle or cortical screws.

Prior to scrubbing, the surgeon uses the iPod to acquire two images (an axial image from the patients MRI or CT, and a lateral image acquired by a C-arm) of the level(s) where fixation is to be placed. No proprietary images are needed. When the surgeon is ready to insert the screws, the iPod is placed into a sterile bag and placed in the sterile field. Using their finger, the surgeon can quickly plan screw trajectory on the touch screen.

The iPod is then placed into a case that easily attaches to a gearshift probe or similar instrument for establishing the screw pilot hole. The sensitive gyroscope of the iPod, as well as the high-performance CPU provides exact, real time, three-dimensional guidance of the instrument. This information is communicated to the surgeon via an intuitive graphical user interface on the iPod screen. Once the instrument is within 1 degree of the planned angle the surgeon is alerted and the pilot hole can be made. The system can be used with any instrument (awl, probe, tap, etc.) and any implant system.

DuraStat, LLC:  DuraStat® Device for Dural Repair

Inventors:  David G. Anderson, M.D., Mark F. Kurd, M.D., Jay Tapper, Jens Johnson

Engineer:  Jens Johnson

Technology Description:  DuraStat is a surgical device for Incidental Durotomy (ID) during spine surgery. It allows the surgeon to deploy a high-quality, direct sutured closure in the most difficult situations by enhancing access, accuracy and safety. DuraStat saves time, increases surgeon confidence while enhancing repair quality and safety as compared to conventional closure systems.

Key attributes of DuraStat include:

  • All-in-one functionality: Combines the functionality of a nerve hook and needle driver into one device. The bayoneted shaft maximizes visualization for both MIS and open applications.
  • Blunt tip with needle contained inside: The blunt tip functions like a nerve hook to locate edges of the ID. Then, while already in position, the needle is deployed one-handed, in an automated fashion, creating a clean, precise passage while avoiding nerve tissue damage.
  • Eliminates supination: Simple, consistent, automated needle passage with the press of a button, eliminates manual needle loading and does not require the space needed for standard suturing technique.
  • Minimizes tissue disruption: Reduces the need for additional exposure to access difficult to reach durotomies. The needle diameter matches the suture diameter to facilitate watertight closure. Automated needle passage is clean and circular, helping to avoiding oblong needle holes which are more prone to CSF leakage.

DuraStat comes as a complete, sterile-packaged dural repair kit, including two DuraStat deployment devices, a double-armed suture and a knot pusher.

Fusion Robotics, LLC:  Fusion Robotics System®

Inventors:  Kevin Foley, M.D., Kevin Frank, Brad Clayton

Engineers:  Kevin Frank, Michael Vogele, M.D., Brad Clayton, Jeff Justis, Pedro Costa, Dave Vaughan

Technology Description:  Fusion Robotics is a simple, compact, efficient, and economical spinal robotics and navigation platform for spine surgery. The unique assembly of technology makes it possible, both clinically and economically, to bring the accuracy and reliability of spinal robotics into many more procedures globally.

There are four key components to the Fusion Robotics platform which combine to make the system unique.

  1. Camera: Miniaturized, lightweight and with a wide-angle view across the sterile field, the camera is rigidly connected to the bedrail within close range of the exposure to increase accuracy and prevent line-of-sight obstructions. The technology is clinically proven, having been used in >15K hip replacement procedures.
  2. Robotic targeting: With a robust bedrail attachment and semi-automatic positioning mechanisms, the robot combines the efficiency of surgeon control with the precision of robotic targeting into one streamlined workflow.
  3. Patient & component stabilization: Rigid, ratcheting arms attach the camera and robot to the surgical table, while a soft yet sturdy patient fixation technology secures the patient to the bed to create a rigid platform for robotic surgery without excess size and bulk.
  4. Procedural integration: The software platform is simple, visual and purposes-built for spine surgery to efficiently import images, plan screw trajectories and execute pedicle targeting with minimal setup and operative time.

The assembly of components addresses numerous workflow and cost inhibitors related to robotics, enabling hospitals to acquire up to four (4) robots for the price of one (1) conventional robot, and making robotics attainable for ambulatory surgery centers (ASCs).

Kuros Biosciences A.G.:  Fibrin-PTH (KUR-113)™

Inventors and Engineers:  Lorenz Vogt, Ph.D., Alistair Irvine, Ph.D., Philippe Saudan, Ph.D.

Technology Description:  Kuros developed a product candidate to activate bone formation based on Parathyroid Hormone (or PTH) and the natural healing matrix fibrin. Unlike BMP-2, PTH only affects cells already committed to form bone. PTH increases the number of bone-forming cells by promoting differentiation of osteoprogenitor cells and proliferation of osteoblasts, while also extending their lifespan.

Using its proprietary technology, a modified PTH is covalently bound to fibrin through the TG-Hook peptide linker which also contains a site for enzyme-mediated release.

For the preparation of the bone graft, modified PTH containing the linker is mixed with a fibrin sealant. The mixture initially forms an easy to use gel, then rapidly solidifies after application. For spinal interbody fusion, the diseased or damaged disc is partially removed, leaving the annulus intact.

The endplates are then decorticated before a cage is inserted. Preclinical studies demonstrate that the excellent flowability and setting properties of Fibrin PTH make it ideal for filling of the cleared disc space and cage using open or minimally invasive techniques. Thus, enabling the prolonged and controlled delivery of PTH at the site of treatment, using only a single application.

As cells infiltrate the fibrin matrix, PTH is gradually released by plasmin cleavage at the enzyme-mediated release sites. Osteoprogenitor cells that are resident in the surrounding tissues are targeted by the hormone, stimulating their differentiation into osteoblasts, and increased proliferation of osteoblasts, resulting in the controlled formation of bone at the site of implantation.

Molecular Surface Technologies, LLC:  Potent Biocompatible and Stable Antimicrobial Treatment for Spinal Implants™

Inventors and Engineers:  Randy Clevenger, Ph.D., Cheoljin Kim, Ph.D., Kristin Blacklock Ph.D., Gordon D. Donald, M.D.

Technology Description:  Molecular Surface (MST) creates active antimicrobial implants by modifying the molecular composition of material surfaces. MST’s permanent covalently bound surface treatment imparts antimicrobial (among other) activity to spinal implants while remaining biocompatible with surrounding tissue. By utilizing proprietary linker, functional end group, and attachment technologies, MST can treat most medical and nonmedical surfaces providing non-eluting antimicrobial properties and unique technology characteristics never thought possible.

The robustness and durability of the surface treatment lies in MST’s linker technology utilizing a catechol-based attachment. MST employs proprietary, patent-pending, quaternized chitosan oligomers as potent functional end groups. This surface treatment is potently bactericidal with no evidence of toxicity to mammalian cells. MST-treated surfaces have demonstrated high potency, killing >99.99% of MSSA, MRSA, and Staph epidermidis in standard ASTM assays.

MST’s primary innovation is the development of methods to deposit and attach its linker molecule through a simple, quick and efficient electrochemical process to drive chemical reactions resulting in stable and robust modified surfaces. This is analogous to and often nearly identical to a typical anodization process.

The result of MST’s unique and proprietary surface modification technology is the delivery of a surface that is remarkably potent in its programmed function. The surface is robust and stable under aqueous conditions. The dimensional scale of these surfaces is less than 100 nanometers, so thin it is virtually “dimensionless” and, importantly, does not alter the mechanical properties of the material.

SurGenTec:  3D Fusion System

Inventors and Engineers:  Travis Greenhalgh, Andrew Shoup, Bryan Hellriegel

Technology Description:  3D (Dilate, Decorticate and Deliver) GraftRasp system allows surgeons to perform a true posterolateral fusion in a minimally invasive fashion. It is the only device of its kind cleared by the FDA to allow surgeons to decorticate bone and deliver bone to an orthopedic site. FDA cleared GraftRasp for U.S. Commercialization on May 18, 2020.

The 3D system works in conjunction with GraftGun, which dispenses bone graft of the surgeon’s choice quickly and accurately. The GraftGun kit includes a universal loading device which enables surgeons to load allograft, autograft, or synthetic biologics into the gun for delivery.

The rasp comes in straight or curved options depending on the anatomy. The foot plates are disposable to ensure sharp teeth on every case. The rasp has a lumen through it which accepts the GraftGun tube. The GraftGun is actuated to deliver bone graft precisely out of the rasp aperture to the surgical location.

The system works well when free handed or when used with our custom dilation set. Without removing the rasp from the decortication site, the GraftGun may be actuated to deliver graft through the aperture of the rasp in between the two transverse processes. To save time and prevent cross contamination surgeon’s also have the option to use one of SurGenTec’s prefilled tube options.

The 3D System may be used minimally invasive, mini open or open cases depending on the technique.

Woven Orthopedic Technologies, LLC:  OGmend® Implant Enhancement System

Inventor:  Alexander  M. Jones, M.D.

Technology Description: The OGmend® Implant Enhancement System was designed to overcome the challenge surgeons face when seeking to achieve adequate fixation in compromised fixation scenarios. It is similar to a wall anchor used in the construction industry yet leverages a biotextile to enhance the screw-to-bone interface to reduce and distribute stress and improve stability between screws and bone immediately and over time.

OGmend is a simple system that can be used in a wide variety of procedures, can be implanted in under 2 minutes, is used in conjunction with existing screw systems, and does not require support or coordination between CSPD/materials and the OR staff (no kits/trays and thus no logistics/sterilization to be managed between a hospital and supplier). A single OGmend implant accommodates a wide range of screw sizes and can be easily stocked for use in the OR when needed.

OGmend is made from a proven material that provides the strength, flexibility, elasticity, and permanence to withstand torque, mold to unique bone environments, and provide lasting effect. It is currently approved for use in spine indications in Europe as well as long-bone trauma indications in the U.S.


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