THE TEN BEST NEW SPINE TECHNOLOGIES FOR 2016 (by Robin Young, Orthopedics This Week)
Robots, 3D printing and clever strategies for navigating the patient’s anatomy in error free ways, dominated this year’s winning technologies. It’s not about newness, it’s about reducing risk and long, expensive hospital stays. The technologies that make that happen for the rank and file spine surgeon were winners for 2016.
The ten winning companies with the BEST new spine care technologies for 2016 were: Cerapedics, Inc., EOS imaging, K2M Group Holdings, Inc., Life Spine, Inc., Mazor Robotics Ltd, Medtech SA, Mighty Oak Medical, Orthopedic Sciences, Inc., SpineGuard, Inc. and Vertera Spine.
CONGRATULATIONS to all of our winners for 2016!
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 2016 to treat back pain. 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 panel of surgeons score every submission on a scale of 1 to 5 (5 being the highest score) for each of the above criteria.
We and our panel of surgeons were impressed that inventors—despite ever growing hurdles to innovation and entrepreneurism in spine—still managed to create a solid group of nearly 40 new products to submit for the 2016 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:
| Alevio LLC | Benvenue Medical, Inc. | Camber Spine Technologies | Cerapedics, Inc. |
| ChoiceSpine | EOS imaging | Globus Medical Inc. | Innovasis, Inc. |
| K2M Group Holdings, Inc. | Life Spine, Inc. | LifeWalker Mobility Products | Mazor Robotics Ltd |
| Medacta International, SA | MEDTECH SA | Mighty Oak Medical | Orthopedic Sciences, Inc. |
| Spinal Balance, Inc. | Spine Wave, Inc. | SpineGuard, Inc. | Stryker Corporation |
| TranS1 | Vertebral Technologies, Inc. | VerteCore Technologies, LLC | Vertera Spine |
| Wenzel Spine, Inc. | |||
The Judges
Our intrepid panel of surgeon judges was:
Neel Anand, M.D.: Dr. Neel Anand is Clinical Professor of Surgery and Director of Spine Trauma at Cedars-Sinai Spine Center in Los Angeles, CA. He is also certified by the Royal College of Surgeons in England and American Board of Orthopaedic Surgery.
Dr. Anand received his medical degree from the University of Bombay, Topiwala National Medical College in India and then completed his orthopaedic residences at the University of Bombay, Royal College of Surgeons of England in London, Royal Liverpool University Hospital in Liverpool, and Albert Einstein College of Medicine Orthopedic Program at the Bronx-Lebanon Hospital Center in New York.
In addition, Dr. Anand completed several fellowship programs: reconstructive spinal surgery at the University of Florida Spinal Health Center in Gainesville; scoliosis and trauma fellowships were completed at the Hospital for Special Surgery through Cornell University in New York.
He is a member of the American Academy of Orthopaedic Surgeons, North American Spine Society, and Scoliosis Research Society. Further, Dr. Anand has presented his research at society meetings, is published in leading peer-reviewed publications, and has contributed to textbook chapters and educational programs in different media.
Bradford L. Currier, M.D.: Bradford L. Currier, MD, is an orthopedic surgeon at the Mayo Clinic in Rochester, MN. He completed his medical degree at Georgetown University and then did a residency in orthopedics at Mayo Graduate School of Medicine. Dr. Currier’s spine fellowship was at the University of Miami in Miami, Florida.
Dr. Currier’s basic science research interests primarily involve tissue engineering strategies to solve clinical problems involving the spine. In addition to bone and cartilage projects, he leads a multidisciplinary spinal cord injury research team investigating spinal cord regeneration. He is a frequent collaborator with the scientists in the Biomechanics laboratory as well as numerous other departments and labs. While Dr. Currier’s clinical research interests are varied and include projects involving the Mayo Cancer Center, he is particularly interested in metastatic and primary tumors of the spine.
Richard Guyer, M.D.: Richard Guyer, M.D. is the Co-founder of the Texas Back Institute and Director of their Spine Fellowship Program. Dr. Guyer is also co-director for the Center for Disc Replacement at Texas Back Institute. Dr. Guyer earned his medical degree from the University of Pennsylvania School of Medicine. He completed his internship at Parkland Memorial Hospital in Dallas, TX and continued with his residency program in Orthopedic Surgery at the Hospital of the University of Pennsylvania. Dr. Guyer then completed two spine fellowships in Ohio and California.
Dr. Guyer holds many honors including founder of the Texas Back Institute Research Foundation and Chairman of the Board for the program. Dr. Guyer has received the Best Doctor Award from D Magazine for multiple years, is past president of the North American Spine Society and winner of the Volvo Award for Low Back Pain Research.
Gil Tepper, M.D., F.A.C.S.: Dr. Gil Tepper M.D., F.A.C.S. of the Valley Spine Center in Santa Monica, CA is one of the top practicing surgeons in the United States. He is the director of the Valley Spine Center in Los Angeles and oversees both the surgical practice at Valley Spine and an array of non-surgical services. Dr. Tepper has been a leader in the field of spine care, from non-surgical intervention to the full range of surgical care for over twenty years.
Dr. Tepper’s particular focus treating disorders of the spine in a personalized, patient focused approach which centers on each individual’s needs and lifestyle. Dr. Tepper is not only a leader in this 360 degree approach to spine care but is also an innovator in spine practice management on the West Coast.
Philip S. Yuan, M.D.: Dr. Yuan is the Chairman of the Department of Orthopedic Surgery at Long Beach Memorial. Currently he is the only physician at Long Beach Memorial that has focused his practice solely on spinal surgery; allowing him to keep up to date on all less invasive surgical options.
A graduate of the University of Michigan medical school, Dr. Yuan specializes in the treatment of all spinal disorders—cervical, thoracic and lumbar. While he emphasizes non-surgical treatment he is also considered to be one of the top spine surgeons in the United States. He is a leader in the application of minimally invasive techniques and is actively involved in cutting edge research to help further improve treatment options for his patients. He has published numerous research articles and presented both nationally and internationally.
So, without further delay, here are the ten best new spine technologies for 2016 arranged according to each company’s name in alphabetical order:
Top Ten Spine Technologies for 2016
Cerapedics, Inc.
Winning Technology: i-FACTOR™ Peptide Enhanced Bone Graft
Category: Biologics
Inventors: Jerome Connor, PhD, Katherine Davis; Nolan Hannigan
(L to R): Stewart Jefferson, Andy Woods, Glen Kashuba, Rick Preusse, Troy Wilford and Josef Vance
i-FACTOR™ Peptide Enhanced Bone Graft is based on the biological activity of the synthetically derived 15-amino acid peptide found naturally in type I human collagen. This 15-amino acid peptide (P-15) is responsible for the attachment and proliferation of osteogenic cells.
i-FACTOR Bone Graft is the first and only bone graft technology FDA approved for cervical fusion. i-FACTOR Bone Graft provides a safe, effective, and proven alternative to autograft harvest as well as avoiding the clinical consequences of using engineered growth factors in the cervical spine.
In a 319 patient IDE (investigational device exemption) study, i-FACTOR Peptide Enhanced Bone Graft was statistically superior to standard of care (autograft). An assessment of overall success, as judged by success in all four primary endpoints (non-inferiority to autograft relative to fusion rate, improvement in neck disability index, and neurological success; and no statistical difference in adverse event rates relative to autograft), was applied to the data analysis in the investigation. The investigational group demonstrated 68.75% overall success. The control group demonstrated 56.94% overall success. The overall success was a statistically significant difference favoring i-FACTOR Bone Graft.
EOS imaging
Winning Technology: spineEOS
Category: Diagnostic and Imaging
Inventors: Joe Hobeika Lukas Vancura
Marie Meynadier, Ph.D.
The spineEOS online 3D planning software is intended for adults suffering from degenerative or deformative spine conditions, as well as for pediatric patients with Adolescent Idiopathic Scoliosis. It allows a surgeon to create a treatment plan to achieve optimal frontal and sagittal alignment based on 3D weight-bearing information from an EOS low dose imaging system.
spineEOS allows surgeons to visualize the pre-operative state of a patient’s spine as well as a suggested correction showing the derotation of each vertebrae. It simulates osteotomies, selects and positions cages and accurately plans the length and shape of the rods, which can be pre-bent based on a 3D printed template. The plan can also be shared pre-operatively with the surgical team, as well as the implant representative to engage the patient in the intended course of therapy.
The deformation of the spine is a tri-dimensional deformity that needs to be analyzed in three dimensions. Additionally, in the specific case of degenerative spine pathologies, it is extremely important to assess a patient’s sagittal balance, including compensatory mechanisms such as knee flexion.
Current spine planning tools are based on 2D conventional X-ray images. They do not account for 3D deformation, resulting in an inaccurate planning and rod shape and length estimation. Furthermore, due to limited field of view of 2D conventional X-ray images, the planning tools cannot assess full patient sagittal balance, unless using stitched images.
spineEOS is based on low dose, EOS stereo radiographic full body images and a 3D model of the spine. It allows surgeons to plan in 3D. spineEOS is based on full body images. spineEOS is proposing several adult and pediatric reference values for sagittal balance and an automatic correction of the spine deformity based on these references and pre-operative 3D values.
K2M Group Holdings, Inc.
Winning Technology: CASCADIA™ AN Lordotic-Oblique Interbody System Featuring Lamellar 3D Titanium Technology™
Category: Biomaterials
Inventors: Hilali Noordeen, Lester Wilson, Tom Morrison, Jennifer Moore, Clint Boyd
Engineering Team: Jennifer Moore, Clint Boyd
(L to R): Lane Major, Jennifer Moore, Dave Fiorella, Todd Wallenstein and Eric Major
The CASCADIA™ AN Lordotic-Oblique Interbody System, featuring Lamellar 3D Titanium Technology, is a 3D-printed titanium interbody implant that provides surgeons with a full range of anatomically designed interbodies for oblique placement through a transforaminal approach. The implant is designed to match sagittal lordosis in an oblique orientation while accounting for the anatomic structure of the endplates. CASCADIA interbodies have a 35° angled posterior wall to accommodate the vertebral anatomy. All CASCADIA Interbody Systems are cleared for use with both autologous and allogenic bone graft tissue in the treatment of patients with degenerative disc disease (DDD) and degenerative scoliosis.
This system—as well as all K2M CASCADIA interbody systems—features the company’s innovative 3D printing to create porous structures with roughened surfaces. This manufacturing approach allows for bony integration throughout an implant.
3D printing with titanium powder allows K2M to grow each implant using a high-energy laser beam. Building the implant in this way creates CASCADIA’s porosity and surface roughness.
This porosity and surface roughness then encourages:
- BONE ONGROWTH: Surface roughness of 3–5 μm throughout the entire implant and is designed to allow for direct bony
- BONE INGROWTH: 500 μm longitudinal channels throughout the implant which, in conjunction with transverse windows, allows bony integration from endplate to
- BETTER RADIOGRAPHIC IMAGING: With approximately 70% porosity the titanium implant allows for a better radiographic
With this new type of interbody design, it can be anticipated that fusion outcomes may be enhanced and the need for more costly bone growth supplements may be diminished.
Life Spine
Winning Technology: LONGBOW®
Category: Minimally Invasive Spine Care
Inventors: Michael Butler, Dan Predick
(L to R – front row): Robin Young – Orthopedics This Week Editor and Publisher, Rita Patel – Director of Marketing, Cady Lauf – Associate Product Manager, Colleen Kathe – Associate Product Manager, Mike Butler (holding award) – President and CEO, Saul Godinez – Product Engineer, Randy Lewis – General Manager, Chris Zakelj – Product Engineer and Tom Bishow – Orthopedics This Weel Vice President of Sales. (L to R – Second Row): Dave Mehl – Product Engineer Manager, Don Jack – Area Vice President of Sales, David Majo – Area Vice President of Sales, Patrick Treanor – Marketing Associate, Rick Greiber – Vice President of Business Development, Greg Palagi – Product Engineer, Dan Predick – Director of Engineering, Rich Mueller – Chief Operating Officer – COO, Mariusz Knap – Vice President of Marketing, Joe Loy – Executive Vice President of Sales, John Gotzon – Senior Product Manager, Garrett Lauf – Product Engineer Manager and Jenn Jesse – Manager of Sales Operations and Human Resource
The innovative LONGBOW Expandable Lateral Spacer System expands laterally, (anterior/posterior) in situ specifically for a direct lateral approach. The benefits of LONGBOW are transferred directly to the patient by offering a custom fit and minimizing tissue retraction and potential nerve damage associated with the lateral access approach.
LONGBOW is inserted at a smaller width compared to a traditional static lateral interbody and is then expanded posteriorly in-situ for a custom fit and maximum coverage of the disc space. It can be filled post-expansion with approximately three times as much bone graft as compared to the average graft volume of a static lateral interbody.
LONGBOW was the first FDA cleared laterally expanding interbody for lateral access. It was received Becker’s 2015 Spine Device Award.
In the lateral approach, surgeons may dissect the psoas muscle in order to access the disc. Nerve damage is a concern since lumbar plexus nerves lie in the posterior one-third of the psoas muscle.
Fixed width lateral implants require the surgeon to dock the retractor posteriorly and closer to the nerves of the lumbar plexus and then retract the muscle significantly to fit a specific implant width into the disc.
By contrast, LONGBOW is inserted anteriorly, away from the nerves, at a smaller width and then expanded in-situ for a custom fit to the patient with minimal muscle retraction. This minimally invasive approach decreases the overall muscle and tissue retraction, potentially reducing tissue and nerve damage and post-operative recovery times.
When compared to static interbody cages, about three times the bone graft can be inserted post-expansion into LONGBOW.
By redefining the surgeon’s starting position for lateral access spine surgery, increasing the amount of bone graft used and minimizing the risk of nerve damage, LONGBOW is a significant technological advancement.
Mazor Robotics Ltd
Winning Technology: Mazor X
Category: Minimally Invasive Spine Care
Inventors: Eli Zehavi, Moshe Shoham, Yossi Bar
Engineering Team: Yonathan Ushpizin, Leon Kleyman, Yael Sirpad, Aviv Ellman, Edo Zucker, Shay Haviv, Boris Bashkansky, Tomer Perunov, Lior Kimron, Yair Schwartz, Nir Ofer, Ofer Regev, Tzafi Primovitch, Natasha Aidland, Dany Junio, Shlomit Steinberg, Matvey Rzhavskiy
(L to R): Isador Lieberman, Jonathan Ushpizin , Christopher Prentice, Eli Zehavi, Ori Hadomi, Aviv Ellman, Anat Kaphan and Boris Bashkansky
Mazor X advances the field of robotic assist devices from trajectory guidance to a total patient treatment.
Mazor X seamlessly integrates preoperative analytics, intra-operative guidance, real-time verification, and other standalone technologies. As a result it offers the spine surgeon a suite of solutions for minimally invasive spine procedures, complex deformities, revisions, and single-position lateral decubitus procedures.
Mazor X’s pre-operative analytics automates anatomy recognition, alignment correction and rod bending. The Mazor X pre-operative analytics software allows the surgeons to perform analytical work outside of the operating room (OR) by experimenting with various surgical options and planning every aspect of the surgery to prevent surprises. The Mazor X planning software can automatically recognize the patient’s spine anatomy. The X-Align software combines biomechanical logic and imaging tools such as a standing X-ray and pre-operative CT scan to automate the alignment plan for each patient. Mazor does not believe that similar technology exists today. The ArcAid is then used to bend and cut the alignment rod based on the corrected alignment from the pre-operative plan. Both X-Align and ArcAid are not yet FDA-cleared.
During the procedure, a bed-attached, bone-mounted surgical arm gives surgeons the ability to guide surgical tools based on the pre-op plan. Mazor X provides immediate, intraoperative on-screen feedback. Mazor X, surgeons have the ability to perform more types of procedures, such as percutaneous sacroiliac joint (SI) fusion and posterior cervical fusion.
Finally, Mazor X provides real-time verification to confirm that the surgery was executed according to the pre-op plan using visual tracking, 2D fluoroscopy-based technology and 3D intraoperative imaging. MZOR believes that its technology addresses the current limitations of real time verification.
With over 15,000 cases and 10 years of experience, Mazor Robotics has pioneered the field of guided spine surgery, and now is creating a paradigm shift in guided spine surgery with the introduction of the third-generation Mazor X system.
Medtech SA
Winning Technology: ROSA® Spine
Category: Minimally Invasive Spine Care
Inventors: Pierre Maillet, Bertin Nahum, Fernand Badano, Patrick Dehour
(L to R): Breana Sullivan, Perry Twyford, Bertin Nahum (CEO of Medtech), Teresa Prego, Austin Mueller, Craig Walters and Doug Krotin
The ROSA® Spine robotic surgery system is designed to increase the safety and reliability of minimally invasive spine procedures. The robot allows physicians to precisely execute minimally invasive surgeries according to highly accurate planning based on intraoperative images. With its six degrees of freedom replicating the movements of a human arm, the robotic arm can easily reach the targeted areas. In addition, the device’s dynamic guidance system tracks the patient’s movement in real time allowing the surgeon to adjust intraoperatively and maintain planned trajectories.
Pathologies treated with ROSA® Spine include degenerative spine disease, tumors, deformity and trauma.
ROSA® Spine provides patients with greater access to minimally invasive surgical procedures on the spine. Worldwide, approximately 3 million procedures with which ROSA® Spine could potentially assist are performed each year. Combined with an intra-operative imaging system, ROSA® positions the instruments according to the pre-defined planning. Its advanced planning, navigation and dynamic guidance functionalities make it easier to perform minimally invasive spine surgery. The minimally invasive nature of the surgeries has the potential to shorten patients’ recovery periods.
Mighty Oak Medical
Winning Technology: Navigation-Enabled Cortical Screw
Category: Diagnostic and Imaging
Inventors: George Frey, M.D.
Engineering Team: Paul Ginzburg Caleb Voelkel
(L to R): George Frey, M.D., Heidi Frey and Brent Ness
What happens when you marry 3D printing with pre-op planning using a CT scan? Answer: a mechanical guidance system specific to each cortical screw. That, in turn gives the surgeon an ability to pre-surgically plan midline trajectories in thoracolumbar spinal fusion surgery. No complex and expensive computer navigation or robots required.
With this system surgeons submit a CT scan that is segmented and converted into a 3D virtual spine. The surgeon’s desired midline trajectories are planned in a 3D environment and then sent to the surgeon for review and approval. Once approved, a Navigation Guide is designed to conform to the trajectory and to guide the drill to the desired entry point for the navigation-enabled screw. Each Guide is 3D printed from a biocompatible resin and is paired with two cortical screws of predetermined size. This simplified approach to navigation makes screw placement in a midline trajectory highly accurate.
The rate of misplaced screws ranges from 10-30%. Despite its clear benefits, surgeons only use navigation in roughly 25% of cases. This is due to access issues, added complexity, added time in the OR, and radiation exposure.
With limited budgets, hospitals should be attracted to a navigation option that is as accurate as the more expensive options but don’t require upfront capital spending.
The Mighty Oak solution addresses these issues and will help make navigation a standard of care in spinal fusion surgery.
Orthopedic Sciences, Inc.
Winning Technology: The Beacon
Category: Diagnostic and Imaging
Inventors: Kristen Radcliff, M.D. and James K. Brannon, M.D.
James K. Brannon, M.D.
The OSI Beacon™ and the Q System Arthroscopes provide the orthopaedic surgeon a means for endoscopic access and inspection of a trajectory through a pedicle in the spine. Improved accuracy of pedicle screw placement and mitigation of untoward litigation following posterior instrumentation as we move toward more less invasive procedures. Direct visualization of the cannulated bony channel will provide valuable information to confirm accuracy of tract and enable the surgeon to identify perforations before neurological injury occurs.
SpineGuard Inc.
Winning Technology: DSG™ Screw
Category: Minimally Invasive Spine Care
Inventors: Maurice Bourlion
Engineers: Olivier Frezal, Stephane Bette, and Maurice Bourlion
(L to R): Pierre Jerome, Patricia Lempereur, Steve McAdoo, Olivier Frezal and Stephane Bette
The DSG™ Screw is a pedicle screw system with a breach anticipation sensor located at the tip of the screw.
This gives surgeons real-time screw guidance and the ability to insert directly into the pedicle without drilling a pilot hole.
It is the unique merger the DSG™ technology (Dynamic Surgical Guidance) bipolar sensor with a pedicle screw—in one device.
The DSG™ sensor differentiates various tissue types based on the analysis of the local electrical conductivity (cancellous bone, cortical bone, blood and soft tissues). Real-time feedback informs the surgeon of changes in tissue type by changes in the pitch and cadence of an audio signal and a flashing LED light. This in turn alerts the surgeon of potential pedicular or vertebral breaches during pedicle screw placement in both traditional and MIS settings.
Moreover, the use of the DSG screw in MIS obviates the need for a k-wire. The result is single-step pedicle screw insertion with an unprecedented degree of accuracy and reduced radiation exposure.
According to the National Institute for Health and Care Excellence, “the main risk associated with placing pedicle screws is pedicle perforation, which occurs when the screw exits the vertebrae. This can result in dural tears, vascular injury, nerve injury or, rarely, spinal cord injury.”
The DSG™ Screw improves pedicle screw placement success rates and lowers radiation exposure for the patient, surgeon, and OR staff. It can also increase workflow efficiency since the DSG Screw system allows for direct insertion of the screw in the pedicle without prior drilling of a pilot hole and decreases K-wire usage.
In short, higher quality of care while saving time and costs.
Vertera Spine
Winning Technology: Porous PEEK COHEREä Cervical Fusion Device
Category: Cervical Care
Inventors: Stephen Laffoon, Allen Chang, Chris Lee
Engineering Team: Stephen Laffoon, Allen Chang
(L to R): Chris Lee, Stephen Laffoon, Allen Chang, and Ken Gall; in the back is Brennan Torstrick
COHEREÔ is the first porous polyetheretherketone (PEEK) interbody fusion device to be cleared by the FDA.
The COHERE three-dimensional interconnected porous PEEK architecture supports bone tissue ingrowth with 60% porosity, 250 um average pore size, and over 99% interconnectivity. It also mimics the structural transition of cortical to trabecular bone.
Surgeons seek an interbody fusion device that will osseointegrate, will not shield or subside, and will not produce any imaging artifacts. Several new titanium implants have also added three-dimensional porosity in order to bone growth and osseointegration. However, in contrast to COHERE, metal implants produce medical imaging artifacts and are stiffer than vertebral bone causing implant subsidence.
PEEK implants have a modulus (stiffness) similar to bone and are radiolucent. However, PEEK implants traditionally have poor osseointegration and cause fibrous tissue formation. COHERE addresses all of these clinical needs and limitations of current fusion device offerings by providing an osteoconductive environment within the porous architecture to enhance implant osseointegration. Because the porous architecture is grown from the base PEEK implant, COHERE’s porous architecture is more durable than metal-coated PEEK implants and will not delaminate.
Lastly, COHERE retains the advantages of traditional PEEK implants including radiolucency (no imaging artifacts) and a modulus similar to vertebral bone to prevent stress shielding and reduce the chance of subsidence.
The COHERE implant has been extensively studied. Researchers have found that the porous architecture on the bone-contacting sides allows for better osseointegration and does not form a fibrous tissue capsule. Further, the bony tissue ingrowth into the PEEK implant pores creates a stronger interface with bone (almost 2X stronger than titanium-coated PEEK implants) and reduces the chance for implant migration or instability.
Unlike porous metal implants, COHERE does not produce any imaging artifacts. Lastly, COHERE implants behave similarly to vertebral bone under compression, exhibiting a comparable modulus and elastic properties as vertebral bone and thereby reducing the chance of subsidence.