Spine technology continues to evolve at a fast pace. Significant development focused on less disruptive procedures allows surgeons to perform a quicker, safer and less costly procedure than ever before. Technology designed to improve procedure accuracy, preserve the patient's natural anatomy and promote faster healing are represented on this list.
Becker's Healthcare developed this list through recommendations from several spine surgeons across the country. Please contact Laura Dyrda at ldyrda@beckershealthcare.com for questions or comments on this list, or to recommend spinal technology for future lists.
Ziehm Vision FD Vario 3D (Ziehm). Ziehm Vision FD Vario 3D is designed for surgical navigation during orthopedic, spine and neurosurgical procedures. The technology includes 3-D images for intraoperative visualization of anatomical structures and can be combined with navigation systems, allowing surgeons to perform image-guided procedures with greater accuracy. The system includes intuitive touchscreens on the C-arm and monitor to change from 2-D fluoroscopy to 3-D mode.
Aero-C (Stryker). Stryker launched Aero-C Cervical Stability System for anterior cervical discectomy and fusions in March 2016. The Aero-C is part of the Aero platform for spinal devices based on patented Compression Technology, an advanced anchor fixation system that draws the vertebral bodies toward the implant, creating compressive forces at the implant-to-endplate interface. The implant is designed for straight forward inline insertion as a more streamlined, less-disruptive approach than traditional screw-based ACDF.
Airo Mobile Intraoperative CT (Brainlab). The Airo Mobile Intraoperative CT can assist surgeons with accurate spinal instrumentation placement and decrease radiation exposure, which is ideal for busy surgeons performing complex cases. The FDA cleared Airo Mobile Intraoperative CT in September 2013. Two years later, Brainlab reported 50 hospitals acquired Airo Mobile Intraoperative CT scanners, with the first shipment headed to the Salt Lake City-based University of Utah Health Care and Detroit-based Henry Ford Hospital.
Altera (Globus Medical). Altera is a minimally invasive fully articulating expandable spacer for spinal fusion procedures. The implant is designed to restore lordosis and maintain sagittal balance. Surgeons insert the spacer at minimized height and articulate it into the anterior position before expanding the implant vertically to optimize fit. Surgeons can then deliver autogenous bone graft into or around the implant.
AnchorKnot (Anchor Orthopedics). The AnchorKnot Tissue Approximation Kit was developed for minimally invasive herniated disc repair. The kit's suture passer is designed to pass the suture into different access locations for repair. In April, Scott Blumenthal, MD, of Texas Back Institute in Plano, performed the first U.S. procedure using the AnchorKnot Tissue Approximation Kit.
Aspen MIS Fusion System (Zimmer Biomet). Zimmer Biomet's Aspen MIS Fusion System is designed for rigid, posterior fixation in T1 to S1. Surgeons take a midline approach to minimize muscle and tissue disruption, and are able to insert the implant. Aspen's central barrel design has load-sharing support and bone graft containment to facilitate fusion. A study published in 2016 found positive two-year results for the system, touting a 94.9 percent interbody fusion success rate.
BoneBac Press (ThompsonMIS). Surgeons can use the BoneBac Press to harvest and collect suction-drilled bone from the surgical site and then press out the fluid to obtain a useable autograft that promotes fusion. BoneBac Press is designed for orthopedic, spine, cosmetic and oral procedures and can reduce surgical costs by reusing this bone instead of autograft or allograft to promote fusion.
BoneScalpel (Misonix). The BoneScalpel is designed for a gentler osteotomy than standard bone cutting tools. The instrument's ultrasonic cutting technology can slice crystalline bone while leaving the tissue largely unaffected. BoneScalpel amplifies an electrical signal and converts it into a high back-and-forth motion, moving 22,500 times per second. The drill is designed to promote efficiency in the OR and lower complication rates and blood loss.
Coflex (Paradigm Spine). Paradigm Spine's coflex Interlaminar Stabilization is a non-fusion solution to relieve lumbar spinal stenosis pain. The procedure can be performed at one or two levels from L1 to L5 for patients with persistent back pain after undergoing six months of nonoperative treatment. The device is placed midline between adjacent lamina of one or two contagious motion segments. The FDA granted coflex approval in 2012 and surgeons recently began using the device in the outpatient setting.
DTRAX (Providence Medical Technology). DTRAX Spinal System is a set of single-use disposable surgical instruments for spinal fusion. The DTRAX system includes four trials, an awl and a multi-angle driver that can reach up to 45 degrees. In May, Providence Medical Technology received $10.5 million in equity financing and entered into a $10.5 million debt agreement with Bridge Bank; the company designated proceeds to expand distributing in the U.S. and internationally.
Exparel (Pacira Pharmaceuticals). Exparel is a non-narcotic local anesthetic administered at the surgical site that can help reduce postoperative pain. Exparel is long lasting, designed to reduce reliance on narcotics, promote mobility sooner after surgery and allow patients to feel more comfortable returning home.
Gordoncoptor Universal Pedicle Screw Removal Device (Gordoncoptor). The Gordoncoptor is a reusable, universal pedicle screw removal device that comes with a ratcheting T-handle. The device has several rod and tulip sizes to accommodate different types of screws so surgeons don't need the original screwdriver for removal. The Gordoncoptor does need the original locking cap nut and compatible wrench to remove the screw.
i-FACTOR Bone Graft (Cerapedics). i-FACTOR Bone Graft, categorized as an "attachment factor," is the only bone graft that uses a novel mechanism of action based on the cell binding of osteogenic precursor cells to a synthetic protein segment found in Type I human collagen, simply known as P-15. Cells bind to the P-15 found in i-FACTOR Bone Graft just as they would bind to the natural amino acid sequence in collagen, the primary organic component in bone. This novel mechanism of action enhances the body’s natural bone healing process, resulting in safe and predictable bone formation. The P-15 technology has been extensively evaluated in scientific and preclinical studies. The published clinical experience with i-FACTOR Bone Graft includes the results of the investigational device exemption study in single-level anterior cervical discectomy and fusion that demonstrated superiority to autograft in overall success.
iFuse Implant System (SI-BONE). The iFuse Implant System is used to perform a minimally invasive sacroiliac joint fusion procedure. Surgeons have used the technology in more than 25,000 procedures since the technology became available in 2009. There is considerable literature supporting the procedure, with more than 50 peer-reviewed publications covering clinical results, biomechanics and economics. In June, Highmark established a positive coverage policy for minimally invasive sacroiliac joint fusion exclusively for iFuse.
Kyphon Xpede Bone Cement (Medtronic). In March 2017, Medtronic received FDA clearance for the Kyphon Xpede Bone Cement for pathological fracture fixation of the sacral vertebral body through sacral vertebroplasty or sacroplasty. Xpede previously received FDA clearance for treatment of vertebral fractures due to osteoporosis, cancer or benign lesions. The quick-to-dough bone cement paired with the Kyphon Cement Delivery System allows clinicians to perform the procedure with minimal radiation exposure from up to four feet away from the patient during the injection.
Lamellar 3D Titanium Technology (K2M). The Lamellar 3D Titanium Technology uses advanced 3-D printing to create structures traditionally considered impractical for manufacturing. The implants are grown through selective application of a high energy laser beam on titanium powder, incorporating a porosity and surface roughness associated with bone growth activity.
Mazor X (Mazor Robotics). Mazor X is a spine surgery guidance platform developed to enhance predictability in spinal procedures. The technology combines analytical tools, multiple-source data and precision guidance with optical tracking, intraoperative verification and connectivity technologies for the surgeon to perform a more precise procedure. Mazor entered into a strategic partnership with Medtronic in May 2016 to co-develop and commercialize the technology, which was launched in October 2016. Over the past year, Mazor reported significant interest in Mazor X, and Medtronic decided to accelerate investment in the company.
M6-C (Spinal Kinetics). The M6-C is an artificial cervical disc that incorporates an artificial nucleus, made from polycarbonate urethane and a polyethylene woven fiber annulus. The M6 is designed to mimic the motion of a natural disc, with the disc's nucleus and annulus allowing 6 degrees controlled range of motion. The M6 has two titanium plasma spray-coated titanium outer plates with keels to anchor the disc into the vertebral body bone.
Mobi-C (Zimmer Biomet). Designed by a French surgical team, Mobi-C was first implanted in November 2004 and eventually received FDA approval in August 2013. Mobi-C became the first cervical disc to receive FDA clearance for two-level disc replacement procedures. Mobi-C is made of cobalt, chromium and molybdenum, and is designed with teeth on the top and bottom to help hold plates to the vertebra.
Endoskeleton with nanoLOCK surface technology (Titan Spine). Titan Spine received FDA clearance to market its Endoskeleton interbody fusion implants with the next generation nanoLOCK surface technology in 2014. The nanoLOCK surface technology increases the amount of nano-scaled textures to up-regulate a statistically significant greater amount of the osteogenic and angiogenic growth factors critical for fusion. In 2016, CMS created a new technology ICD-10 code for a nanotextured surface on an interbody device and the nanoLOCK was first to receive access to this code.
NVM5 (NuVasive). The NVM5 platform is a set of intraoperative technologies designed for spine surgery, including multimodality monitoring of the spinal cord and nerves. The system also includes refinements such as the rod-bending technology Bendini. NVM5's modalities include simulated electromyography, motor evoked potentials and computer-assisted surgery applications.
Tritanium (Stryker). Tritanium PL is a posterior lumbar cage designed for bone in-growth and biological fixation. The implant has a microstructure of cancellous bone enabled by Stryker's patent protected 3D Additive Manufacturing process.
XLIF (NuVasive). More than 350 published clinical studies support the efficacy of eXtreme Lateral Interbody Fusion over 10 years. NuVasive developed the minimally invasive procedures as a lateral lumbar interbody fusion, approaching the patient's spine from his or her side to avoid disrupting back muscles. Studies show XLIF is associated with less blood loss, shorter hospital stay and reduced postoperative recovery time when compared with the traditional approaches to surgery.