Spine technology has made big advancements in the last decade, and the pandemic accelerated the move to more precise, less invasive care.
Twenty innovations in spine:
Artificial intelligence. Medtronic CEO Geoff Martha predicted artificial intelligence and machine learning would be the next frontier in medtech in late 2020, and despite the pandemic many companies and surgeons have continued to explore AI applications in spine. AI-guided surgery could make procedures more precise, eliminate reoperations and lower the overall cost of care. There are also AI applications in radiology and imaging that can assist surgeons in identifying issues more efficiently.
Augmented reality. Augmented reality technology took the spine field by storm in 2020 after the first procedures using Augmedics' Xvision took place at Johns Hopkins in Baltimore. The Xvision spine system includes a headset for real-time spinal anatomy projection, allowing for 3D visualization of the spinal anatomy during surgery. It is designed to appear as if the surgeon has X-ray vision into the patient's anatomy to navigate instruments and implants while looking directly at the patient instead of a screen. Since last year, many other surgeons have begun to use the technology, and Augmedics has grown as well. The company raised $36 million in series C funding in March.
Awake spinal fusion. The early adopters of awake spinal fusion techniques are seeing interest among fellow surgeons grow amid the COVID-19 pandemic. These spinal fusions are performed without general anesthesia, so the patient is awake throughout the procedure and can begin recovery more quickly than patients who undergo traditional fusions. The procedure can be performed in ASCs and typically lowers the overall cost for an episode of care.
Big data. Surgeons have more data at their fingertips than ever before, and in the coming years they'll be able to use it for better patient outcomes. They can also use data about cases to standardize care processes among surgical groups, identify gaps in care and make sure care is delivered efficiently. Surgeons who aren't already intimately familiar with their cost data will soon have access to much more information as healthcare organizations ramp up value-based care efforts.
Disc regeneration. Spine surgeons and scientists are teaming up at academic medical centers across the U.S. to develop solutions for disc regeneration. While it is still in the very early stages, over the next decade technology is expected to advance to the point where surgeons could repair annular tears biologically and reverse disc degeneration. If proven effective, disc regeneration techniques would disrupt the spine field and prevent nagging pain from getting to the point where patients need surgery.
Enabling technologies. In the early 2000s, the spine field experienced a renaissance of innovation in spinal devices and implants to make procedures less invasive. However, in the last few years, true innovation has shifted from the implant to technologies that make surgery more efficient, personalized and precise. Enabling technologies include robotic systems integrated with imaging pre-planning devices, neuromonitoring and computer navigation, which allow surgeons to control every aspect of surgery and lower radiation exposure.
Endoscopic spine surgery. The endoscopic spine surgery technique has been popular overseas for years and now is gaining steam in the U.S. While the technique has many benefits as a less-invasive procedure for decompressions, among other surgeries, it comes with a learning curve. However, as more spine cases move into the outpatient setting and an emphasis is placed on value-based care, more surgeons are seeing the value of an endoscopic approach and training on the technology. Early career surgeons are championing the technique as well after learning it during fellowships and at professional meetings.
Imaging. The imaging systems used in spine surgery have much more advanced applications than the traditional MRI and CT scan. Specialized systems such as NuVasive's Pulse platform integrates images with data on alignment, neuromonitoring and navigation capabilities. Imaging is also becoming 3D with many new applications. GE Healthcare gained FDA clearance for the OEC 3D surgical imaging system for spine and joint replacement in March to make planning for complex and routine surgeries easier. Intraoperative imaging and guidance systems are also advantageous because surgeons know screws are placed correctly before the patients leave the operating room.
Infection control. Surgeons are taking steps to reduce surgical site infections during spine procedures by taking several measures, from improving air flow and disinfectant efforts to using vancomycin powder on the surgical site. They can also use Surgx, a sterile antimicrobial gel applied to the surgical wound to protect against infections for up to five days.
Multilevel disc replacements. Artificial disc replacement technology has evolved in the last decade to fit better into the patient's natural anatomy than spinal fusions. Patients typically have better range of motion after disc replacement procedures, and studies show superior outcomes as well. Zimmer Biomet's Mobi-C was the first disc to receive two-level FDA clearance in 2013, and NuVasive's Simplify Disc was the second, cleared April 6. Centinel Spine's prodisc L is also cleared for two-level lumbar disc replacements. The demand for motion-preserving techniques is growing, and there is room for continued innovation in disc replacements to prevent adjacent segment disease.
Nonopioid pain management. The opioid crisis in the U.S. sparked a need for new methods of dealing with patients' pain, especially during and after surgery. Many surgeons are turning to nonopioid solutions, such as physical therapy, spinal cord stimulation or interventional pain injections to aid patients with back pain. When patients do need surgery, they can use long-acting local anesthetics like Pacira's Exparel intraoperatively to lower pain for the first 24 to 48 hours after surgery. The local anesthetics control pain so patients can move sooner after surgery, and have spurred the migration of spine surgeries with traditionally long hospital stays to outpatient ASCs.
Patient positioning. The way spine patients are positioned in the operating room can make the procedure easier on surgeons and more comfortable for patients. Surgeons traditionally achieved the optimal patient position by rolling up blankets or using pillows to prop up the patient in different ways. The Bone Foam Sideline Lateral Positioning System is designed to position patients so surgeons have optimal access to the spine. From the way patients are positioned to instrument attachments on the table, a more personalized experience than ever before can be curated by surgeons.
Precision medicine. EHR data within organizations and large national patient registries gather data points, and artificial intelligence can gather information based on specific parameters to help spine surgeons see trends among large and small, select patient populations. They can then use the data in discussions with patients for shared decision-making. Coupled with patient-specific implants and robotic-guided procedures, surgeons are able to provide a customized care experience for patients from their first meeting until they are pain-free.
Prone transpsoas approach. Spine surgeons in partnership with Alphatec Spine developed the prone transpsoas approach as a more streamlined alternative to the traditional lateral approach. Surgeons can use the approach to perform spinal fusions on patients in the prone position, accessing the disc space laterally through the psoas muscle. The technique reduces preoperative positioning time, and surgeons can perform posterior surgery simultaneously when needed.
Robotics. Nearly every major orthopedic company has a robotic spine surgery offering, with Medtronic's Mazor X Stealth Edition holding the largest market share. Most spine-focused robotic systems offer surgical pre-planning based on the patient's CT scans and pedicle screw guidance during surgery. Robotic systems are becoming the preference for early career surgeons who train on them during fellowships, and some systems are even making their way into ASCs. While the systems have evolved a long way in the last decade, there are still opportunities for robotic systems to provide the same value in the spine field as they do for total joints.
Scoliosis surgery. Technology advancements are making complex spine surgeries less invasive and hold big promise for improving scoliosis surgery outcomes. Robotic technology will have more applications beyond pre-planning scoliosis procedures to predict the amount of lordosis surgeons can achieve with fusions. Surgeons also have also begun using augmented reality technology in scoliosis cases to make procedures more precise. Vertebral tethering for pediatric patients with idiopathic scoliosis was approved in 2019 and is being evaluated for long-term outcomes as an alternative to fusion.
Spinal cord injury treatment. Exciting advancements in spinal cord injury treatment are returning motor function to patients who experience severe trauma. A study from Yale University in New Haven, Conn., published in April, found patients who were injected with stem cells derived from their own bone marrow reported improved motor function after spinal cord injuries. Baltimore-based Johns Hopkins scientists have also begun developing ultrasound devices for patients with spinal cord injuries with a $13.5 million grant from the Defense Advanced Research Projects Agency.
Stem cells. Medtech companies are in the beginning stages of testing stem cells for spine patient applications. In January, the first spinal fusion using a ViBone Moldable cell bone matrix was performed. The technology, designed by Aziyo Biologics, promotes bone growth with cancellous bone particles and demineralized cortical bone fibers and particles within the matrix. UC Davis Health in Sacramento, Calif., also launched a human clinical trial using stem cells to treat spina bifida in fetuses before birth.
Telemedicine. The COVID-19 pandemic forced physicians and patients to rapidly adapt to virtual care options, and the spine field was no exception. Spine surgeons quickly transformed their practices to see patients via video conferencing, gather information through online forms and share images seamlessly between providers. They were also able to conduct postsurgical visits and second-opinion consultations virtually. Telemedicine is here to stay and moving forward, there will be more functional monitors and text communications to track back pain and spine surgery patients as they recover.
3D printing. The spine field continues to expand applications for 3D printing, both for model spines and implants. Orthofix received FDA clearance for its 3D-printed device, Construx Mini Ti Spacer System, in April. Nexxt Spine and Stryker also have 3D-printed implants. In other fields, companies use 3D printing for customized implants and developing customized spine implants could be an opportunity for companies the future.