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7D Surgical Wins 2017 Spine Technology Award for Flash™ Align
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The ten companies with the BEST new spine care technologies for 2017 are: 7D Surgical, Amniox Medical/Tissue Tech, Lifewalker Mobility Products/Protostar Inc., Lite Run Inc., Mighty Oak Medical, Orthofix Inc., TrackX Technology, LLC, TranS1, VersaSpine, LLC, and ZygoFix, Ltd.
CONGRATULATIONS to all of our winners for 2017!
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 2017 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.
- 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 2017 Orthopedics This Week Spine Technology Awards.
Submitters
We offer our thanks and deep appreciation to the engineering teams, surgeon inventors and the following companies for submitting their best ideas this year.
| 7D Surgical | Amniox Medical/Tissue Tech | Anatomics Pty Ltd. | Bio2 Technologies, Inc. |
| EOS Imaging | Hensler Surgical Products, LLC | K2M Group Holdings | Life Spine |
| Lifewalker Mobility Products/Protostar Inc. | Lite Run Inc. | Mighty Oak Medical | Neurostructures, Inc. |
| Orthofix, Inc. | Osseus Fusion Systems | Prosidyan, Inc. | SI-Bone, Inc. |
| Spinal Balance, Inc. | Spineology, Inc. | Stryker Corporation | SurGenTec LLC |
| TrackX Technology, LLC | TranS1 | VersaSpine, LLC | VerteCore Technologies, LLC |
| Whale Imaging, Inc. | ZygoFix Ltd | ||
The Judges
Our intrepid panel of judges were:
Jean-Jacques Abitbol, M.D.: Jean-Jacques Abitbol, M.D. is an orthopedic surgeon specializing in spinal surgery. He is the immediate past President of the North American Spine Society and has testified before Congress as a patient advocate relative to health care issues. He has worked in the field of orthopedic surgery for the past 25 years, and is Board Certified in Orthopedics.
Dr. Abitbol is committed to providing exceptional care for his patients. He has three office locations which serve the San Diego, Riverside and Imperial Counties. He provides treatment for workers' compensation, personal injury and private patients, accepting a variety of private insurance plans.
Dr. Abitbol is trilingual, speaking Spanish, French, and English. Many of his staff members are bilingual. This benefit allows added comfort for our Spanish speaking patients.
James B. Billys, M.D.: Dr. Billys, who is also course director for the Castellvi Spine Meeting, is a board certified spine surgeon who earned his undergraduate degrees from Notre Dame and his medical degree from Jefferson Medical College in Philadelphia. He interned and completed his residency at the Duke University Medical Center. He is fellowship trained in three areas—immunology research at Duke, hand and microvascular reconstructive surgery at Davies Medical Center in San Francisco and spine surgery at Stanford University.
Lisa Ferrara, Ph.D.: Dr. Ferrara is a widely published expert in the field of biomechanics and is frequent consultant to medical technology companies. She also is a frequent lecturer at surgeon meetings and serves on multiple scientific and medical advisory boards. Recently she was appointed to be a member of the Advisory Committee for Biotechnology in Southeastern North Carolina.
Dr. Ferrara previously served as the Director of the Spine Research Laboratory in the Department of Neurosurgery and Orthopedics at The Cleveland Clinic with a research focus on musculoskeletal biomechanics and the development of implantable MEMS sensors for various biomedical applications. She was awarded the Who’s Who Award in Technology in 1999, the NASS Award for Outstanding Research in 1995, and is the recent recipient of the Healthcare Entrepreneur of the Year Award for Coastal North Carolina.
Dr. Lisa Ferrara has received numerous accolades, advised the Medical Device Advisory Committee to the FDA, and provided consulting services about spinal disorders for ABC News.
Kern Singh, M.D.: Dr. Singh is an internationally renowned minimally invasive spine surgeon. In addition to teaching minimally invasive techniques to neurosurgeons and spinal surgeons, he was recently an invited guest lecturer to Saudi Arabia. He is an inventor in his own right and is extensively involved designing minimally invasive spinal instrumentation.
Clinically, Dr. Singh's primary interests include the minimally invasive treatment of complex degenerative disorders of the cervical, thoracic, and lumbar spine. Dr. Singh also specializes in minimally invasive treatment of spinal tumors and adult spinal deformities.
Dr. Singh has published his findings in major medical journals (more than 200 publications, presentations and book chapters). He most recently won awards for his research including Best Paper at the North American Spine Society (NASS) and Society of Minimally Invasive Spinal Surgery (SMISS) International Meetings in 2013. He is also the principal researcher in several FDA clinical trials involving cervical disc replacements and motion-preserving spinal technology.
Dr. Singh was also appointed to serve as the chair of the Spine Program Committee for the American Association of Orthopaedic Surgeons (AAOS) Annual Meeting from 2017-2020.
A graduate of Jefferson Medical College, where he graduated Magna Cum Laude, Dr. Singh completed his training at Emory University in a combined Orthopaedic and Neurosurgical spine fellowship.
So, without further delay, here are the ten best new spine technologies for 2017 in alphabetical order.
Top Ten Spine Technologies for 2017
7D Surgical
Winning Technology: Flash™ Align
Inventors and Engineers: Zahra Faraji-Dana, Ph.D., Michael Leung, MSc; Adrian Mariampillai, Ph.D.; Beau Standish, PEng, Ph.D.; Victor Yang, M.D., Ph.D., PEng, FRCSC
Zahra Faraji-Dana, Ph.D., Beau Standish, PEng, Ph.D., and Victor Yang, M.D., Ph.D., PEng, FRCSC
No lengthy CT set up time. No intraoperative radiation. Full 3D optical visualization via Machine-vision Image Guided Surgery system—which digitizes the patient’s anatomy and performs registrations using ONLY visible light.
Flash™ Align creates individual virtual models of each spine vertebrae from a preoperative image set, which are used to characterize the shape of the spine intraoperatively. Each individual vertebra can be tracked in 3D space, enabling quantitative measurements, such as Cobb angles, de-rotation, and sagittal balance, and advanced visualization of the deformity in real time.
As the surgeon manipulates the shape of the spine at any point in the surgery, a simple press of the foot pedal updates position of each individual vertebra on the monitor. The surgeon receives continuous intraoperative feedback of the correction without the use of X-rays. Flash™ Align addresses the problem of progressively measuring spine anatomy intraoperatively as rods and screws are inserted and the spine shape changes.
Amniox Medical/TissueTech
Winning Technology: Respina
Inventor: Scheffer Tseng, M.D., Ph.D
Engineer: Ek Kia Tan
Dan Huenefeld, Colleen Turner, Tom Dugan, and Barry Hassett
Respina UC/AM is Cryopreserved Umbilical Cord/Amniotic Membrane Matrix for use in microdiscectomies. It is an easy to use, fully resorbable biological matrix that aids in the restorative healing of minimally invasive microdiscectomy procedures.
Respina is for placement in the annular defect following removal of disc fragments during microdiscectomy. The material contains cytokines, growth factors and, most importantly, the HC-HA protein complex which has been shown to directly reduce local inflammation and orchestrate the healing environment in and around the annular defect.
A controlled, randomized clinical study showed clinical improvements over control as early as 6 weeks and throughout the 2 year evaluation period. At 2 years, zero patients with Respina reported a recurrent herniation while 7.5% of the control group (standard discectomy without matrix) reported a recurrent herniation.
Protostar, Inc dba Lifewalker Mobility Products
Winning Technology: Upright Medical Walker.
Inventors: David A. Purcell, Tom Pan, Peter Fellingham, Nebojsa Sataric
Engineers: Tom Pan, Peter Fellingham, Nebojsa Sataric
Robin Young and Dr. Steve Garfin
The LifeWalker™ Upright, is a next-generation medical walker that specifically addresses the deficiencies of current walkers, including fall risk, slouching, and lack of user confidence and comfort. In addition, patients with Kyphosis who are bent forward benefit from the upright position, by reducing pressure on spine, heart, and lungs.
An inventor developed the Lifewalker for his wife who has Kyphosis, RA, spine pain, and Ataxia, and found that the prototype helped many others as well. His wife had had 15 spine surgeries and 2 RA surgeries, and years of spine pain. Dr. Steve Garfin, Distinguished Professor and Chair of Orthopedics and Spine at UCSD encouraged the inventor to further develop and produce the product to help other spine patients. It is being manufactured now and is in use by out-patient departments in a number of hospitals and by individuals.
A clinical trial of two cohorts of patients [spine and elderly] at the Rehabilitation Institute of Chicago in 2016 demonstrated that patients are able to walk longer, with less spine pain, and require less oxygen using the LifeWalker versus using a standard rollator. Examples of those who are helped by our product are shown in videos in our company web site.
Lite Run Inc.
Winning Technology: ExoSuit
Inventors: Doug Johnson, John Hauck, Mark Johnson, Odd Osland, Pete Bobgan
Engineers: Pete Bobgan, John Hauck, Mark Johnson, Doug Johnson, Bruce Wigness
Pete Bobgan, Bruce Wigness, Mark Johnson, Odd Osland, Doug Johnson, and John Hauck
The Lite Run ExoSuit uses differential air pressure inside a specially-designed suit to effectively unweight some of patient’s body weight onto Lite Run’s proprietary walker. A patient’s effective body weight may be reduced by over 50%. For example, a 180-pound patient can “weigh” only 90 pounds. This means the weight the patient needs to support on his or her own is greatly reduced, making walking and balance easier. In addition, a complete “sit-to-stand” feature provides major assistance in standing up from a wheelchair or bed.
Anti-gravity science. Just as the pressure of water in a swimming pool pushes a swimmer's body up and out of the water, the air pressure inside the ExoSuit lifts a patient off the ground. Lite Run is operated with an easy-to-use touchscreen that allows therapists to set the amount of weight to be taken off a patient. Once the therapist keys in the desired weight, air pressure begins to increase in the suit, and as it inflates, it exerts an upward force on the patient.
ExoSuit minimizes the time between stroke, traumatic brain injury or a spinal cord injury and starting rehabilitation. ExoSuit gets patients upright and walking sooner, more comfortably than standard of care harnesses or robotic exoskeletons.
ExoSuit is also safer for both patients and rehab therapists—particularly when working with obese patients. ExoSuit greatly reduces the physical burden placed on staff. Finally, ExoSuit lowers labor costs by enabling a single therapist to handle patient transition to and from the system and manage the gait training therapy.
Mighty Oak Medical
Winning Technology: X-Caliber Porous Pedicle Screw
Inventors: George Frey, M.D., Gregory Kana
Engineers: George Frey, M.D., Gregory Kana
Heidi Frey, Gregory Kana, Brent Ness, Brad Clayton, and Rob Bronersky
The general design of the pedicle screw has remained largely unchanged. Pedicle screws provide a point of fixation on the spine in order to apply corrective and stabilizing forces. But, due to the variable and dynamic nature of the forces associated with the spine, pedicle screws experience a great deal of stress. Too often, pedicle screws are points of failure for an otherwise successful spinal fusion procedure.
The X-Caliber Porous Pedicle Screw provides improved biomechanical pedicle fixation, regardless of bone quality or the forces being applied to the screw. X-Caliber includes both porous and solid aspects which are fused together into a single solid construct. The structure, density and location of the porous aspects facilitate osteo-integration and/or provide patient-matched biomechanical characteristics.
The X-Caliber’s unique design characteristics allow the screw to achieve the desired amount of purchase in osteoporotic bone or with semi-rigid constructs that demand continuous and indefinite dynamic loading.
The screw is 3D printed, contains both solid and porous elements and has a design which can produce screws with a range of different mechanical characteristics that can change along its length as desired. 3D printing allows for open pore geometry and roughened surface finishes.
Porosity, thread form and core geometry can be adjusted to allow for precise adjustment of the screw’s modulus of elasticity to reflect a more anatomically suitable modulus, osteo-integrative design features, and more even load distribution along the shank of the screw.
Finally, the 3D printed geometry is less dense than a standard pedicle screw, which reduces CT artifact and improves the screw’s appearance on imaging.
Orthofix, Inc.
Winning Technology: STIM onTrack™ Mobile App
Inventors: Les Bowling, Bobby Harris, Monica Kermat, Parul Jain
Engineers: Les Bowling, Bobby Harris, Monica Kermat, Parul Jain, Jeff Culhane, Sterling Denton, Philip Garman
James Ryaby Ph.D., Jeff Culhane, Jonelle Juricek, Terrence Wright, and Brad Niemann
STIM onTrack™ is a mobile application designed for use with smartphones and other mobile devices. It helps patients adhere to their prescription, including daily treatment reminders, a device usage calendar, links to educational resources, and access to Orthofix’s Patient Care team.
It also includes a first-to-market feature that sends real-time data the patient’s physician on how each patient is adhering to prescribed treatment protocols. STIM onTrack mobile app obtains usage data directly from the bone growth stimulation device via the stimulator’s new imbedded Bluetooth feature.
Information is redefining the spine fusion patient recovery experience. As described in the February 3, 2009 issue of the Annals of Internal Medicine: “Patients who have a clear understanding of their after-hospital care instructions, including how to take their medicines…are 30 percent less likely to be readmitted or visit the emergency department than patients who lack this information.” – a study funded by the Agency for Healthcare Research and Quality (AHRQ).
By sharing compliance information with the physician and helping facilitate patient post-op recovery, Orthofix is finding ways to improve clinical outcomes by partnering throughout the continuum of care with physicians.
TrackX Technology, LLC
Winning Technology: TrackX
Inventors: Robert Isaacs, M.D.
Engineers: Randall Campbell, Samuel Johnston, Robert Hull, David Skwerer
David Skwerer, Julie Darrow, and Robert Isaacs, M.D.
TrackX easily and efficiently tracks surgical instruments in real surgical time using ultra low dose radiation imaging.
TrackX takes image guided surgery to a new level of precision and accuracy by increasing and recalibrating each new image taken. TrackX snaps onto the surgical instrument and its real time instrument tracking starts working. There is NO change in surgical workflow or operating room setup. But there is a 90-95% reduction in overall case radiation.
With TrackX, surgeons have an unparalleled instrument tracking experience.
TrackX is simple to use. When an instrument enters the fluoroscope’s field of view for the first time, take an X-ray. When that same instrument returns to the fluoroscope’s field of view it seamlessly moves across the screen without any additional X-rays or subjecting the patient, physician, and entire OR to additional radiation.
With TrackX, the imaging emulates live fluoroscopic imaging but with only 1-2 low-dose scouting X-rays.
TrackX allows surgeons to substantially reduce the number of X-rays needed to accurately and safely advance instrumentation, place implants and restore anatomy—all while using low-dose imaging and reducing overall OR time.
TranS1
Winning Technology: Pylon MIS Posterolateral Graft Delivery System
Inventors: Scott Noble, Leighton LaPierre, Ryan Arce, Brandon Arthurs, Yuta Okkotsu, Dave Eyvazzadeh, Jeff Schell, Gerald Schell
Engineers: Scott Noble, Leighton LaPierre, Ryan Arce, Brandon Arthurs
Leighton LaPierre, Jeff Schell, and Ryan Arce
Pylon MIS Posterolateral Graft Delivery System is a reusable spinal instrument which allows surgeons to perform one of the gold standards of fusion (posterolateral gutter fusion) through a minimally invasive approach.
With Pylon, surgeons can prepare the fusion site and deliver bone graft along the lumbar transverse processes in a controlled and minimally disruptive manner. This instrument can be used in conjunction with MIS posterior pedicle screw fixation.
It is an all-in-one instrument and requires only a single instrument pass above or below the level(s) to be fused.
After placing percutaneous pedicle screw wires, a small 1 cm incision is made superior or inferior to the pedicle screw k-wire and the instrument is passed in an arced trajectory until the instrument is sitting on the transverse processes below the posterior musculature at the level to be fused. Once positioned a protective sheath can be retracted to expose a decorticating tool to roughen and prepare the fusion site along the transverse processes. Once decorticated, bone graft (allograft or autograft) can be delivered through the same instrument. A unique “static plunger” design allows the graft to be delivered precisely and confident to the prepared fusion site.
VersaSpine LLC
Winning Technology: VersaSpine Dual-Ended Minimally Invasive Pedicle Screw System
Inventors: Syed Aftab Karim, M.D., Ashok Gowda, Ph.D., Charles Houssiere, Ravish Patwardhan, M.D.
Engineers: Ashok Gowda, Ph.D., Charles Houssiere, Manish Ahuja
Ashok Gowda, Ph.D., Syed Aftab Karim, M.D., and Ravish Patwardhan M.D.
The VersaSpine System is a minimally invasive patented pedicle screw implantation system, based upon the novel dual-socket pedicle screw which allows both anterior and/or posterior fixation.
The system addresses many scenarios in a more efficient manner including:
- Posterior-Anterior fixation using the same pedicle screw;
- Procedures such as corpectomy performed in a lateral decubitus position to be performed entirely without repositioning the patient;
- Construct extensions / later revisions being able to be performed without as extensive a subsequent procedure.
The VersaSpine Dual-Ended MIS pedicle screw system allows a potentially far stronger biomechanical construct while also providing versatility in extension of posterior and anterior constructs without entire existing system revisions clear advantages to patients, surgeons, hospital administrators and, importantly, insurance companies.
ZygoFix Ltd.
Winning Technology: ZLOCK Facet Fusion System
Inventors: Uri Arnin
Engineers: Uri Arnin, Ofer Levy
Uri Arnin and Ofer Levy
The ZLOCK is a posterior stabilization system designed to lock the facet joint of the lumbar spine. The ZLOCK anchors into both superior and inferior articulating processes, immobilizing its motion and providing stabilization.
The ZLOCK is 3D printed from Titanium which enables its unique geometry and characteristics.
The device is composed of a matrix of columns which are connected by thin elements. Each column has an upper and lower angled keel. Additional front and rear elements assist the deployment procedure. While the columns take up any load applied in the joint, the keels which anchor into the upper and lower joint bones resist any shear motion. The thin connecting elements enable the columns to flex and thus the device to adjust its geometry to the anatomy when pushed into position.
The ZLOCK allows for posterior stabilization in a percutaneous minimally invasive procedure without using screws or an external construct such as pedicle screws and rod. Rather, the ZLOCK leverages the natural bridge formed by the superior and inferior processes to obtain stabilization.
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