Continuously investigating innovative approaches to old techniques or developing novel technology for uncharted territory, device companies flood the spine industry with instrumentation and clinical support.
Philip Schneider, MD, and Michael Goldsmith, MD, of The Centers for Advanced Orthopaedics in Bethesda, Md., highlight the various impacts of technology in the spine industry.
Minimally invasive spine surgery
Minimally invasive spine surgery may offer the most impactful opportunity in the spine industry right now.
"We're at a really interesting time, because we have a lot of technology, but things are evolving pretty rapidly," Dr. Goldsmith says. "[MIS] is making what we already do easier and gives us the ability to get people better and to recovery a little quicker."
Surgeons first leveraged MIS technology for discectomy procedures. Next came laminectomy and then single-level fusion. Dr. Schneider sees multi-level fusions as the next growth area for MIS.
"Every company that has resources to do it, is going that direction," says Dr. Schneider. "And we're talking about posterior and anterior and lateral surgery, and combinations of different types of approaches in the minimally invasive market."
Dr. Goldsmith agrees, noting the significant advancement in instrumentation for MIS procedures, which require better retractors and lighting. But, expandable cages have really changed the game.
"We see a number of companies, including companies like Globus and Integrity and newer companies, coming out with novel expandable cages, and that's changed how we do the less invasive approach," adds Dr. Goldsmith.
And within the realm of cages, companies are unveiling surface technology to encourage bone ingrowth by covering surface areas with metal or ingrowth porous coating.
Navigation technology also allows surgeons to perform less invasive approaches, by assisting with a 3-D view of pedicle screw placement. Dr. Goldsmith praises Medtronic's O-arm for giving him the confidence of knowing exactly where he places screws.
"That's novel and unique, as we've always had ways to place screws and cages, but now we can both navigate those screws intra-operatively in real time and see a CT scan in the OR before leaving the OR to avoid the problem of postoperative nerve irritation from hardware related causes," he says.
Companies are also starting to make headway with biologics in the MIS industry.
"Biologics are feeling their way out right now; there wasn't a whole lot of science around it, but [companies] are compiling biologics impregnated into hardware [now]," explains Dr. Schneider.
Standard biologics use a patient's own bone to encourage bone growth with its cellular material. A patient can only withstand so much bone removal, however, especially from the iliac crest due to the associated significant morbidity and complication rates.
Enter stem cells, which hold potential when injected into the disc space.
"There are a number of studies investigating the regrowth of cartilage in the disc space through stem cell technology. However, this technology is not there yet and is not FDA approved," says Dr. Goldsmith. "That [would] change the narrative of how we treat patients. Instead of fusing, we would look to regenerate their cartilage in certain cases."
Spine continues to shift to the outpatient setting, as patients seek lower costs and quicker recoveries. CMS is supporting this push with new spine codes; in November 2016, CMS added 10 new spine codes for the ASC payable list in 2017:
• Spine bone autograft local add-on (20936)
• Spine bone autograft morsel add-on (20937)
• Spine bone autograft struct add-on (20938)
• Additional neck spine fusion (22552)
• Insert spine fixation device (22840)
• Insert spine fixation device (22842)
• Insert spine fixation device (22845)
• Insj biomechanical device (22853)
• Insj biomechanical device (22853)
• Insj biomechanical device (22859)
Although payers are getting on board with ambulatory surgery centers, they are doing so slowly. Without favorable reimbursements, ASCs lack the funds to afford advanced technologies available to hospitals, such as robotics and 3-D products.
"The insurance companies and Medicare could save a ton of money [with ASCs,] and ASCs could have all the same technology the hospitals do," explains Dr. Schneider.
Enhanced perioperative pain management is also creating an improved experience for patients in the outpatient setting.
"I think we're getting quicker recoveries, less pain and less bleeding because of that whole perioperative experience," Dr. Schneider says.
Additionally spine companies are honing in on the outpatient opportunity, developing technologies adaptable for ASCs. Dr. Goldsmith points to cervical spine cases as driving a lot of volume in the outpatient setting, with companies offering devices and simple trays for easy process and quick turnover. For lumbar spine cases, many companies offer a minimally invasive set designed specifically for the outpatient environment.
Making its mark on the spine industry, robotics are designed to yield high accuracy and low complication rates. The worldwide spinal surgical robotics market is currently valued at $26 million, likely growing to $2.77 billion by 2022, according to a ResearchMoz analysis.
Many companies are on the forefront of robotics development, but Dr. Goldsmith believes the technology hasn't quite met its potential, yet.
"[Robotics] is in its infancy," he says. "We want to look for something that saves time and increases efficacy and right now what we have doesn't do either one of those."
Dr. Goldsmith anticipates companies will develop a robotic technology that syncs with a navigation system intraoperatively within the next three to five years.
"Right now using them is more science than reason," he adds. Companies integrating robotics with navigation will hit the jackpot for improved care.
Dr. Schneider agrees, noting he is not a necessarily a believer in robotics, but is an avid navigation user.
Artificial disc replacement
Currently focused on the cervical spine, the industry has found favorable results for artificial disc replacement.
"I think the work has to do with expanding into the mutli-level area," Dr. Schneider says. "I think we will see more use of 3-D imaging in the OR — that is going to become the standard in the future, and a big growth area for the imaging companies."
Dr. Schneider also believes the lumbar spine will have another go in the artificial disc replacement realm, with more surgeons attempting multi-level procedures.
Dr. Goldsmith adds substantial evidence backs disc replacement technology in the cervical spine, demonstrating superior results compared to one- and two-level fusions.
In a study published in Spine, researchers compared patient outcomes for those undergoing single-level total disc replacement in the cervical spine versus those undergoing single-level anterior cervical discectomy and fusion in an ASC. TDR patients demonstrated statistically significant intragroup improvements in visual analog scale neck and arm pain scores as well as neck disability index scores.
"When you look out past four years, disc replacements are better and an anatomical restoration of the body," says Dr. Goldsmith.
Pictured: Dr. Schneider and Dr. Goldsmith.