Companies with the best new spinal care technology of 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 our 2021 winners!
This annual award rewards inventors, engineering teams, surgeons and their companies who have created the most innovative, durable and practical back care products in 2021. To win this week's Orthopaedic Spine Care's Best New Technology Award, the new technology must meet the following criteria:
Our panel of experts scores each submission based on each of the above criteria, on a scale of 1 to 5 (5 is the highest score).
The 2021 Best Spine Technique Award won a record number of techniques. We would like to express our gratitude and deep gratitude to the engineering team, surgeon inventor and company that submitted the best ideas this year.
Paul Anderson, MD: Dr. Anderson is a nationally recognized expert in spinal trauma and complex cervical diseases. His research expertise includes the development of spinal fixation implants and artificial cervical discs. Dr. Anderson's research expertise includes spinal fixation implants, the development of artificial cervical discs, and basic research on disc regeneration. His current projects include sleep disorders in orthopedic patients. The purpose of the study is to find out whether a person's orthopedic problem type (spine, shoulder, hip or knee) affects their sleep, continuous motion analysis of the human spine and a classification system for lumbar disc herniation.
Scott Blumenthal, MD: Dr. Blumenthal is a spine surgeon at the Texas Back Research Institute and the first and only surgeon in the United States to dedicate his practice to the research and application of artificial disc replacement. Dr. Blumenthal played an important role in bringing artificial disc replacement surgery to the United States. Dr. Blumenthal graduated from Chicago Northwestern Medical School. His general surgery intern and plastic surgery residency are at the University of Texas Health Science Center. He is a clinical assistant professor of plastic surgery at the University of Texas Southwest, Dallas, and a continuing contributor to the first non-profit foundation created for joint replacement patients.
Peter Deman, MD: Dr. Deman is a minimally invasive and endoscopic spine surgeon at the Baker Institute in Texas. He graduated with honors from Stanford University after completing a Bachelor of Science in Biological Sciences. His medical degree comes 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 resident is in the Special Surgery Hospital in New York. Dr. Derman completed his spinal surgery scholarship at Rush University Medical Center in Chicago, Illinois. In private time, Dr. Derman enjoys staying healthy, sailing and brewing craft beer with his wife.
Dr. Vijay Goel: Dr. Goel is a distinguished university professor in the field of orthopedic bioengineering at the University of Toledo and a professor at the McMaster-Gardner Foundation. He is the co-director of the Center for Disruptive Musculoskeletal Innovation (CDMI) and is well-known for his pioneering research in the field of spinal diseases. He has received numerous publications and peer recognition, including those from four professional associations. Four lifetime achievement awards. Dr. Goel has licensed his four concepts to the company and performs various tests required by the FDA for most multinational companies and startups. Dr. Goel was the founding co-chair of the ASTM Spinal Implant Committee and laid the foundation for the development of implant evaluation guidelines.
Douglas Orr, MD: Dr. Orr is a full-time physician in the Cleveland Clinic Campus Spine Health Center and Orthopedic Surgery. Dr. Orr's interests include adult spine surgery, minimally invasive surgery, and deformity surgery. His research focuses on spinal surgery results, spinal biomechanics and biomaterials. Dr. Orr came to the Cleveland Clinic from Hamilton Health Sciences, Ontario, where he served as the Plastic Surgery Director of the Plastic Surgery Department. Dr. Orr has also served as a clinical assistant professor of surgery. He has received numerous awards, including the Best Teacher Silver Hip Award from the Resident of the McMaster University Orthopedics Program and the Robin Sullivan Orthopaedic Research Excellence Award at the University of Toronto Orthopedic Research Day. He has written many publications and lectures for medical journals and conferences.
Therefore, without further ado, here are the top ten best new spine technologies in 2021 in alphabetical order.
Top Ten Spine Techniques in 2021
Carlsmed, Inc. Award-winning technology: aprevo™ Inventor and engineer: Mike Cordonnier and Niall Casey
Technical description: aprevo is the first digital-to-device patient-specific intervertebral technology for the treatment of adult spinal deformities (ASD). The system uses patient imaging data to create surgeon-specific and patient-specific surgical plans, and manufactures personalized 3D printed spinal equipment to implement each plan. The size, shape, front lobe and coronal angle and height of each titanium aprevo device are highly individualized. The system also provides an anatomical interface that matches the patient's vertebral endplate topology. The aprevo device can be implanted through the anterior, lateral, or transforaminal approach. Data is uploaded via a secure user interface, and within a few weeks after the plan is approved, sterile kits with personalized implants and implant inserters are delivered to the operating room. There is no need for expensive reprocessing of traditional stock implants. The FDA granted aprevo a breakthrough technology status because it provides more effective ASD treatment than standard care—a first in the field of spine or orthopedics. Beginning in October 2021, the Center for Medicare and Medicaid Services (CMS) awarded aprevo the highest ever new technology additional payment (NTAP) for spine or orthopedics, up to $40,950, and a transition pass (TPT) for outpatient surgery.
There is no need for expensive reprocessing of traditional stock implants. The FDA granted aprevo a breakthrough technology status because it provides more effective ASD treatment than standard care-the first and only one in the spine or orthopedics field. CMS will grant aprevo new technology X codes and 65% of new technology additional payments (NTAP) from October 2021.
Centinel Spine LLC Award-winning technology: prodisc L Inferior Angled Endplates Inventor: Dr. Thierry Marnay Engineer: Ed McShane
Technical description: These unique endplates are designed to transfer the lordotic angle of Prodisc L implants to the inferior endplate, expanding the range of options available to surgeons to better solve the different problems of the patient's lumbar spine anatomy and pathology. With these lower angle end plates, the surgical level is horizontal, reducing the sacral slope and minimizing the shearing force on the implant. The angle of the lower plate also raises the lumbosacral joint in the pelvis, optimizing lateral bending and axial rotation, which may improve the overall movement of L5-S1 and L4-L5. The manufacturer Centinel Spine has released six angled options, including lower endplates with 3° and 8° lobes and upper endplates with 3° lobes. The prodisc L system is still the only total disc replacement system approved for lumbar two-level use in the United States, and these inferior angle endplates are now available to international and American surgeons.
DisCure Medical winning technology: DisCure System Inventors and engineers: Yossi Gross, Yuval Mandelbaum, Yehuda Zadok
Technical description: The DisCure system is a miniature, fully implantable pulse generator (IPG), used to treat early and mid-term intervertebral disc degenerative disease (DDD), reverse the degenerative process and restore the healthy function of the intervertebral disc. DisCure is implanted through minimally invasive surgery under local anesthesia. The system restores the natural negative charge and voltage gradient in the intervertebral disc, restores the flow of fluid, oxygen and nutrients into the nucleus, improves the environmental conditions of the intervertebral disc cells; increases the volume of the intervertebral disc and improves fluid exchange-expelling metabolic by-products, acid, MMP and cytokines . In DDD, degenerative changes cause the pumping function to fail, cell apoptosis and ECM, and GAG levels decrease. The reduction of proteoglycan and GAG will reduce the natural negative charge in the intervertebral disc and further weaken the healthy pump function, causing the intervertebral disc to eventually dry out and collapse. This system restores negative charges by sending electrical pulses to the optical disc. DisCure is being evaluated by the FDA based on its breakthrough device designation.
Dymicron winning technology: Triadyme®-C Cervical artificial disc Inventors: Dr. Bill Pope and Dr. Bao-Khang Nguyen Engineers: Jeffery Taylor, MD, David Harding, Ph.D., Steven Ulmer, Dean Blackburn, Eric Lange
Technical description: Triadyme-C is the next generation of artificial cervical intervertebral discs. It uses a proprietary polycrystalline diamond material and patented Tri-Lobe joint design to simulate the complex coupled movement of natural intervertebral discs while providing stability throughout the range of motion. The excellent durability of polycrystalline diamond almost eliminates the risk of long-term wear debris. Polycrystalline diamond is a sintered whole of diamond crystallites, fused together at a pressure of 1 million pounds per square inch and a temperature of 2,700 degrees Fahrenheit. The material is fully compatible with X-ray and CT diagnosis, and compatible with MRI, with almost no artifacts, and clear images can be obtained at the treatment level.
The novel Tri-Lobe hinge mechanism design replicates the natural movement of the spine, while maintaining energy stability and aligning the load axis with the center of rotation. Three spherical lobes cooperate with three non-congruent spherical pockets, which makes Triadyme-C a self-centering device that allows movement on various axes. These physiological characteristics are very similar to those of natural intervertebral discs—the ball-and-socket joints currently used in the device cannot achieve these characteristics.
Globus Medical, Inc. Award-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 Nocia, Steve Tracy, Robert LeBeouf, David Cleary, Alex Cruel, Saumya Shah
Technical description: Excelsius3D is a three-in-one imaging platform that integrates cone-beam CT, fluoroscopy and digital radiography into one adaptive unit. Intelligent functions-such as base and rack position memory for simple return to different positions, omnidirectional wheels that slide seamlessly in any direction along the floor, and advanced collimation technology in all three imaging modes-accelerated imaging settings, Fine-tuning and acquisition. The internal and external Cs of the system rotate independently for a complete 360-degree rotation. The compact footprint and the elimination of a separate observation station, as well as the three joysticks of the tactile touch handle and handheld controller, simplify the transportation of the system and allow precise movement and positioning. The integrated navigation array accelerates the registration of ExcelsiusGPS® and ExcelsiusHub™ for all three navigation workflows.
icotec Medical, Inc. Award-winning technology: cervical lamina icotec
Technical description: icotec's anterior cervical plate is made of BlackArmor®, which is a material made of carbon fiber reinforced polyether ether ketone (PEEK) using icotec's unique composite flow molding (CFM) process. The result is that the implant has the radiolucency of PEEK and the strength of carbon fiber, enabling the implant to withstand the mechanical requirements and stresses of front neck stabilization while still providing the visibility needed for tumor treatment. The excellent structural integrity is attributed to the interwoven, uncut 3D fiber structure, which makes it comparable to standard titanium implants in terms of stiffness and strength. Due to the radiolucency of X-ray, CT and MRI, the BlackArmor cervical plate is a real one. Small tantalum markers embedded in the tip and head of the screw help to improve the visibility of intraoperative and postoperative imaging. The icotec anterior cervical bone plate implants are available in 1 to 4 segments, ranging in length from 21 to 94 mm; all options are 18 mm in width. In addition, the cervical lamina options are designed to match the natural lordosis of the spine, and their lordosis angles are 6° and 22°. The self-tapping screws have diameters of 4.0 mm and 4.25 mm, lengths of 13 mm and 15 mm, and have a fully threaded tapered head designed to prevent extraction by being firmly locked in the plate. In addition, the fixed skull screw angle prevents penetration of the lower endplate of the vertebral body.
Misonix, Inc. winning technology: PrepFx powered by neXus; ultrasonic disc preparation inventor and engineer: Dr. Nicholas Theodore, Dan Voic, Paul Mikus, Christopher Ballor, Alex Darian
Technical description: Misonix’s neXus ultrasonic interbody fusion preparation (UIFP) solution is an ultrasonic surgical suction system that uses a combination of small mechanical vibration and cavitation to provide clinicians with a way to enter the ideal pathology and remove Comprehensive solutions for defects and ensure that the intervertebral disc space is fully closed/sealed. The herniated disc technique in spinal surgery fails to provide a single solution that can solve all aspects of discectomy, including access to the herniated site, removal of disc material, and sealing of the disc. Before the launch of the ultrasonic microdiscectomy solution supported by SonaStar on neXus, microdiscectomy has always been a complicated process, requiring multiple instruments/equipment using various technologies. The UIFP solution allows hard tissue management (eg bones, intervertebral disc materials, endplates, etc.) and simplifies the complex workflow of one of the most common spinal decompression applications, with only one device.
PrecisionOS technology winning technology: Multi-user virtual surgery training and education for scoliosis Inventors and engineers: Nhu Nguyen, Frank Lueck, Simon van de Lagemaat, Kevin Chorney, Colin O'Connor, Cale Werake, Thoufeeq Ahmed, Marie Lamouret, Rob Oliveira With Danny Goel, MD
Technical description: PrecisionOS is a developer of a new type of virtual technology that uniquely combines key decision-making with technical skills training to improve the professional knowledge of surgeons. The software provides surgery and skills training, combining all surgical steps in a case-based scenario with real-time feedback to achieve surgical capabilities. The training takes place in a high-fidelity virtual reality (VR), fully immersive environment that truly simulates a real operating room. Surgeons and trainees usually practice patients to improve their skills. The substitutes are saw bones and corpses. Both of these options are expensive, inconvenient, and do not provide performance feedback, nor are they related to the trainee’s desire to improve their skills objectively. VR is cost-effective and can be used to educate surgeons around the world through collaborative meetings. New surgical techniques often require a steep learning curve and can hinder people from learning new skills (especially if the previous method of completing the surgery is also very successful). Providing a platform for faster and more effective learning will benefit new surgeons around the world-including remote areas that may be difficult to reach or areas in the world where there are not many orthopedic surgeons.
Sectra Winning Technology: SECTRA IMA® Inventors and engineers: Per Svedmark, Henrik Olivecrona, Stefan Lindholm, Anders Hedblom, David Rundqvist, Olof Sandberg, Rolf Scheiderbauer
Technical description: Sectra's IMA technology is designed to detect postoperative prosthesis loosening in patients with pain. It is a non-invasive imaging technique that enables clinicians to see and accurately quantify the main signs of prosthetic joint and/or implant loosening (ie, actual body movement). In these sometimes very challenging and critical diagnostic situations, this greatly reduces ambiguity. IMA is suitable for patients with lumbar and cervical spine. IMA is based on acquiring two CT scans of the patient, and the patient changes position between the two CT scans. This change in position, extension, and flexion can cause different loads on the relevant segments of the spine. After that, IMA uses image processing algorithms to cover specific vertebrae or implants in two scans. This enables clinicians to jump between the exact same slices and positions in the two scans, and provides a direct visual high-precision impression of any load-induced movement. IMA also allows precise quantification of the size of the movement, in millimeters and degrees, on all 3 base axes. The technology is low-dose compatible.
TheraCell, Inc. Award-winning technology: TheraFuze DBF® Fiber Anchor™ Inventor and engineer: Andrew Carter, Ph.D., Nelson Scarborough, Ph.D., Bradley Patt, Ph.D., Ian McRury, Ph.D.
Technical description: TheraFuze DBF fiber anchor is a new type of product. Its function is very similar to that of plasterboard anchors, but it is used in orthopedics, especially spine pedicle screw fixation. It is designed to provide immediate improvements in screw fixation in initial surgery and revision cases. The fiber anchor is a kind of biological implant, which has osteoconductivity and osteoinductivity, which is conducive to long-term healing. It is molded from 100% demineralized cortical bone fibers, which are produced using the company's patented manufacturing process to produce long and strong fibers that retain the natural nano-morphology of bones. Fiber Anchor’s design inputs include a tapered shape for easy insertion, a centered screw design, and a proximal flaring to prevent downward movement during insertion. Tests have shown that the pull-out force of the fiber anchor is more than doubled compared with the screw without the fiber anchor. Histological evaluation of the sheep model confirmed the development of new bone formation at week 4 and bone remodeling juxtaposed with screws and defect edges at week 12. The fiber anchor is now in clinical use, and a hollow version for placement on a guide wire is being developed.
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