20 Cutting-Edge Innovations in Spine

Written by Laura Dyrda | April 01, 2014 | Print  |

 Spinal innovations and techniques have grown tremendously over the past decade, especially within the last few years. Here are 20 cutting-edge innovations in spine.

 

This list is sponsored by SpineCraft.

 

Minimally invasive lateral techniques. NuVasive was among the first companies to develop a minimally invasive lateral spine surgery approach, an alternative to the traditional anterior or posterior approaches. Founded in 1999, the company is now the third largest spine device company in the United States and fourth globally with more than 90 products spanning the lumbar, thoracic and cervical spine.

 

NuVasive's eXtreme Lateral Interbody Fusion procedure is the only lateral procedure now validated with 10 years of clinical experience. It has more than 140 published clinical studies supporting outcomes, reduced blood loss, shorter operating room time and hospital stays when compared with traditional fusions.

 

Over the past few years, several other spine companies have released lateral approach devices making an impact on the field today, including the VEO Lateral System from Baxano Surgical for direct visualization for lateral fusion surgery. The Society of Lateral Access Surgery, supported with NuVasive funding, was created to foster research, surgeon education initiatives and peer-to-peer communication advancing lateral techniques. The society participates in advocacy events, patient education and research to develop the future of lateral access technology and bring it to a broader patient base.

 

Cervical disc replacement. Artificial disc replacement has been around for nearly two decades, but gained popularity recently as long-term data shows equal and better outcomes in comparison to spinal fusion. Several new cervical discs are on the market, including the Mobi-C from LDR, which has FDA approval for both one- and two-level indications.

 

The market is expected to grow over the next several years as physicians and patients look for motion sparing fusion alternatives. This is especially true as reimbursement roadblocks are removed; the American Medical Association announced cervical disc replacement will receive a Category I CPT code beginning in 2015 and multi-level disc replacements will fall under the Category III CPT code.

 

Clinical data also supports cervical disc replacement. Medical Director and Director of Spine Education at Cedars-Sinai in Los Angeles Hyun Bae, MD, presented 48-month safety and efficacy data for the Mobi-C cervical disc compared to ACDF at the 2013 North American Spine Society Annual Meeting. While average neck disability scores and improvement were similar among both patient groups, reoperation rate was significantly lower for Mobi-C (3 percent at one level) compared with ACDF (9.9 percent at one level).

 

Among the first five-year data to be released was on the ProDisc II from Synthes in January 2014. The data demonstrated improvements in VAS and ODI scores at all levels, higher patient satisfaction and a low complication rate.

 

Stem cell technology. Many companies are working on investigational trials and basic science research into stem cell technology. Stem cell technology has gathered steam over the past few years and several projects are examining their potential use for spine. In particular, adult stem cells use to enhance spinal fusions is becoming a more popular concept.

 

Mesoblast also recently released positive outcomes from the company's 100-patient Phase 2 clinical trial using allogeneic mesenchymal stem cells to potentially repair intervertebral discs or regenerate new bone. Other companies are in phase 1 trials for cell-based technology that could have an impact on disc health and regeneration in the future.

 

PEEK. Implantable polyetheretherketone has made significant headway over the past decade to become a common biomaterial used in spinal devices. Invibio Biomaterials Solutions introduced PEEK-OPTIMA, the first in an extremely versatile family of polymeric biomaterials, in 1999. PEEK-OPTIMA devices provide controlled visibility through X-ray, CT and MRI technologies allowing surgeons to verify device placement postoperatively and assess the healing site.

 

These polymers are used to manufacture several FDA-approved spinal devices. Literature supporting PEEK in cervical cases shows improved spinal alignment and geometry, shorter hospital stays, less blood loss, fewer complications and good fusion rates.

 

Biological treatment for spinal cord injury. Geron began the first clinical trial of a therapy derived from human embryonic stem cells in spinal cord injury patients in 2009, but shut down the trial a year later due to financial difficulties. The company, which maintained the trial was not shut down for "lack of promise" among spinal cord patients — according to an article in the New York Times — but rather because the company decided to focus on experimental cancer therapies. However, patients who began therapy during the trial's short period were allowed to continue and researchers will gather data which could serve as a base for future development.

 

But Geron wasn't the only company after spinal cord injury treatment; StemCells Inc., was also conducting trials, along with InVivo Therapeutics. Instead of focusing on regeneration exclusively, InVivo concentrates on neuroprotection and its products are intended to protect the spinal cord after primary injury by mitigating the bleeding, inflammation and further cell death after SCI while promoting neuroplasticity.

 

Data on InVivo's technology was first published in 2002 and has since demonstrated success in prompting functional recovery from SCI in several models, including rodent and non-human primates. In April 2013 the FDA granted InVivo its investigational device exemption human trail approval for a 15-month study on its biopolymer scaffold product, and the company received permission to update the trial in January 2014.

 

Robotic navigation. Robotic navigation and guidance are gaining popularity among several medical specialties. Although some contention remains among spine surgeons, an increasing number are looking into the potential benefits of using robotic technology. Mazor Robotics is currently the only company producing a mechanical guidance system for the spine that has FDA clearance and CE marking.

 

The company's Renaissance system has been used in thousands of procedures worldwide for increased precision in minimally invasive surgical cases as well as complex spinal deformities. The technology allows surgeons to plan the operation in a virtual three-dimensional environment to create a surgical blueprint for each individual patient. Studies show the technology may be able to improve accuracy and reduce radiation exposure when compared with fluoroscopy during spinal cases.

 

A study published in early 2014 shows using robotic guidance shortened spinal procedure time and decreased radiation exposure by 74 percent when compared with fluoroscopy and 50 percent when compared with navigated augmentation. In a January 2014 interview with Becker's Spine Review, Mazor Senior Vice President Christopher Prentice mentioned that while verification on screw placement often happens post-action, he hopes the technology will evolve to the point where surgeons can view their progress in real time and execute the surgical plan while instantaneously knowing they are still "on plan."

 

Anterior vertebral body tethering. For adolescent patients with scoliosis, anterior vertebral body tethering potentially represents a huge leap forward in fusionless treatment. In the right patient, the procedure can prevent the convex side of scoliosis from growing until the concave side catches up, allowing the spine to correct without undergoing fusion. The surgeon performs the procedure thorascopically through three small incisions and runs the tether through the screw heads to correct the curve; the tether can be adjusted and loosened if necessary to prevent over-correction.

 

Only a few centers in the world have this procedure, but Amir Samdani, MD, Chief of Surgery at Shriners Hospital for Children — Philadelphia — and one of the surgeons performing this procedure — expects more spine centers to adopt the procedure in the future. Dr. Samdani has performed more than 70 anterior vertebral tethering procedures and of those studied, more than 90 percent avoided fusion.

 

Genetic testing. The ability to better predict how adolescent idiopathic scoliosis will develop presents a big opportunity to improve care and lower costs for patients. ScoliScore developed the AIS prognostic test to help physicians determine which patients with mild AIS are likely to develop severe scoliosis with 99 percent accuracy.

 

The saliva-based test collects DNA from patients to measure DNA markers for progressive or protective genes that impact the spinal curve. The results are then converted into a numbered scale to measure the patient's likelihood to develop severe scoliosis. This test has the potential to eliminate routine physician visits and multiple imaging tests traditionally used to monitor scoliosis progression and can help physicians and patients develop the appropriate treatment plan.

 

Genetic testing may also have a place in disc degeneration treatment in the future, but testing is still in the basic science stages.

 

Spinal fusion. The spinal fusion field has developed significantly over the years, and despite competition from motion preserving and non-fusion devices, it remains among the most profitable sectors in spine. Advancements to promote fusion in the biologic realm are exciting, but non-fusion still occurs in some patients and the imaging to track progress is expensive.

 

Intellirod Spine has developed an implantable wireless sensor technology to assess spinal fusion while minimizing costs associated with CT scans. The system is more quantifiable than traditional imaging and can identify complete healing sooner without additional patient exposure to radiation.

 

Other technology is gaining recognition around the country; last year, a Chicago Innovation Award was given to Life Spine for its AILERON Expandable Posterior Fusion System, which has an in-situ expandable core that offers patient matched expansion to custom fit the procedure.

 

Finally the InFill Direct Lateral Fusion system including the InFill Graft Delivery System from Pinnacle Spine Group is emerging as a solution for skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion. It is filled with graft material in situ, allowing for complete contact between the vertebral bodies and graft material. In 2013 an independent study confirmed surgeons can achieve up to 94 percent more graft material between the vertebral bodies using the InFill system.

 

Spinal cord stimulation. In March 2013 the FDA approved Medtronic's SureScan, a spinal cord stimulator compatible with MRI. The device was used with the first patients in the United States last year to treat chronic back and leg pain. Patients are able to undergo MRI without having to first remove the SCS, which represents an important leap forward in the technology. SureScan also offers protection against patient injury and device damage with a shielded Vectris lead to reduce the risk of thermal tissue damage.

 

Additional protective technology, such as filtered feedthroughs, protects the neurostimulators by preventing RF energy from the lead outside of the stimulator. The device was tested and modeled across more than 10,000 different patient scenarios and 100 million simulated scans for patient safety.

 

Interbody fixation at L5/S1. There are currently a few techniques for less invasive interbody fixation at L5/S1, including AxiaLIF and Oblique Lateral Lumbar Interbody Fusion. Baxano Surgical's Axial Lumbar Interbody Fusion is a minimally invasive alternative approach to traditional fusion procedures. Originally developed by TranS1 — which acquired Baxano last year — AxiaLIF received a Category I CPT code in 2013. The technology was originally developed more than a decade ago and was performed on more than 14,000 patients before receiving a CPT code.

 

Amendia's Zeus OLLIF device is constructed of PEEK and includes aggressive teeth to prevent implant migration. The patented cannulated design helps to safely guide the implant past the nerve root and the instrument set is designed to minimize operating time. Scott Spann, MD, founder of Pantheon Spine, also developed the lateral access device Epiphany to access L5/S1 for patients with advanced degenerative disc disease.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
Imaging technology. Spinal imaging technology made great leaps forward in the past decade and continues to strive toward better imaging for spine patients. While several companies fall into this arena, Esaote North America's G-scan brio weight bearing MRI and NeuroLogica's BodyTom portable computed tomography bring exciting developments to the field. The G-scan brio utilizes second generation MRI technology with improvements in both receiver coil and XP technology for sharper images at a lower cost. Patients can receive images in a clinostatic or orthostatic position because the machine's magnet rotates from 0 to 90 degrees.

 

NeuroLogica's BodyTom is a battery powered machine that can be transported from room to room and is compatible with PACS, surgical navigation, electronic medical records and planning systems. In January 2013, Samsun Electronics acquired NeuroLogica and a year later the company announced a partnership with Stryker to provide surgical navigation with the portable CT scanner.

 

Finally, the LevelCheck tool from Johns Hopkins University/Siemens Healthcare is designed for intraoperative imaging to avoid wrong-site surgery. The technology allows surgeons to localize structures defined in preoperative three-dimensional imaging with intraoperative fluoroscopy and operates without additional tracking or navigation equipment.

 

Sacroiliac joint fusion. Less invasive sacroiliac joint fusions are emerging as a solution for patients with lower back pain caused by the SI joint. SI-BONE's iFuse has been used in more than 10,000 procedures worldwide, a milestone announced at the beginning of 2014. The device received FDA clearance in November 2008 and two studies were published last year showing more pain relief and less complications with the minimally invasive procedure. One of the studies also showed less blood loss, reduced operative time and shorter length of stay than the open procedure.

 

Zyga Technologies, founded in 2008, emerged with the SImmetry Sacroiliac Joint Fusion System for patients with SI joint dysfunction. The company received FDA clearance for the SImmetry system in 2011. In March 2014, the American Medical Association's CPT Editorial Panel announced it would establish a Category I CPT code for minimally invasive SI joint fusion, which previously had a Category III code. The change will go into effect Jan. 1, 2015.

 

Pedicle screw technique advance. Pedicle screw placement ease and accuracy has improved over the past several years. Technology such as SpineGuard's PediGuard has been at the forefront of these advances. PediGuard is a handheld, wireless device that can detect possible vertebral cortex perforation during pedicle preparation for screw placement. The device also alerts the surgeon prior to a breach by analyzing the electrical conductivity of the surrounding tissue in real time. There have been more than 25,000 surgeries performed with this technology around the world.

 

Another advance in pedicle screw placement is Precision Spine's Reform Pedicle Screw System, which has a triple lead thread for more precise and efficient placement. The Reform system received FDA clearance in August 2012.  

 

Minimally invasive deformity correction. Technology has evolved to the point where even more complex surgeries, such as scoliosis procedures, can be done with a less invasive approach. Neel Anand, MD, director of spine trauma at Cedars-Sinai Spine Center in Los Angeles combined three minimally invasive procedures to treat adult patients with scoliosis: lateral lumbar interbody fusion, direct lateral interbody fusion and rod placement with Medtronic's CD Horizon Longitudinal System.

 

Some systems, such as SpineCraft's AIM Minimally Invasive Surgery System, are focused on less invasive deformity correction. The AIM system includes a broad selection of screw/rod delivery instruments and implants to treat deformity and degenerative conditions. Another example is the VIPER 2 Spine System from DePuy for non-cervical pedicle fixation and non-pedicle fixation can also be used for scoliosis procedures.

 

Less invasive procedures can lead to quicker recovery times and lower pain scores, and device companies realize their importance. K2M's products are also geared toward a minimally invasive approach for complex spinal procedures. This year the company celebrated its 10th anniversary and currently has 57 spinal technologies and techniques. K2M set its sights on the future this year; the company submitted a draft registration statement on Jan. 25, 2014.

 

Interspinous fixation. Interspinous fixation devices were designed and are currently being tested as alternatives to pedicle screw and rod constructs for interbody fusion procedures. Interspinous fixation systems are designed to increase motion when compared with fusion procedures. The FDA has cleared several devices, including the X-STOP Interspinous Process Decompression System and ZIP MIS Interspinous Fusion System from Aurora Spine.

 

A two-year multicenter, randomized, controlled study comparing patients who received nonsurgical treatment to those who underwent surgery with the X-STOP Spacer showed 93 percent of patients didn't require additional surgery, but 7 percent had the device removed or a laminectomy. The ZIP MIS Fusion System received FDA clearance in December 2013, and showed success in 40 surgeries performed in Europe before gaining clearance. By that time, the company had distribution agreements with 35 distributors for sales in the United States.

 

Vertebral compression fracture repair. The vertebral compression fracture repair market is expected to reach $2.82 billion by 2019, and the global market for kyphoplasty will reach $1.47 billion by 2019, according to a Transparency Market Research Report from February 2014. Medtronic dominates this market capturing 80 percent of the market share, with devices including the Kyphon for balloon kyphoplasty.

 

However, Benvenue Medical's Kiva VCF Treatment System received FDA clearance in January as an implant-based solution for vertebral augmentation — a departure from the traditional balloon kyphoplasty. This is the first new approach to treating vertebral compression fractures in more than a decade and the clinical studies to support the system's FDA clearance application met or exceeded the performance of balloon kyphoplasty.

 

The Kiva system features proprietary cylindrical implant made from PEEK-OPTIMA instead of relying solely on a bolus of bone cement, which is also a new approach to vertebral augmentation.

 

Outpatient spine devices. More complex procedures are moving to the outpatient setting — including total joint replacements and some spinal procedures. The outpatient setting can improve quality and reduce cost of care, and as a result patients, physicians and payers are now looking to ambulatory surgery centers and hospital outpatient departments as the next frontier for spinal procedures.

 

Device manufacturers have taken notice as well, and some are beginning to develop minimally invasive devices and techniques for the outpatient setting. For example, Paradigm Spine's coflex Interlaminar Technology is a stabilization device indicated for one- or two-level lumbar spinal stenosis decompression procedures. Richard Kube, MD, performed the first two-level coflex procedure at Southern Illinois Surgery Center in 2013 and now more surgeons are making the switch.

 

Higher-acquity cases, such as fusions, are also moving to the outpatient setting. Devices such as the VariLift-L from Wenzel Spine — the only stand-alone, expandable interbody fusion device cleared by the FDA for lumbar procedures — can be used in the ASC setting. The company also has the VariLift-C designed to eliminate the need for plates and screws during ACDF procedures in the inpatient and outpatient settings.

 

Other device companies also realize the unique challenges of the outpatient setting and are addressing those issues. DePuy Synthes Select developed a business model to bring outpatient orthopedic and spine technology to ASCs, catering specifically to the outpatient environment.

 

Pain management. Spine surgeons wouldn't be able to perform less invasive techniques without important advancements in anesthesia and pain management. The traditional open procedures require general anesthesia and hospital recoveries. However, developments in anesthesia technique and shorter surgical time allow anesthesiologists to control patients' pain postoperatively with fewer side effects.

 

Better pain management techniques also promote quicker ambulation and faster recovery. During the recovery period, Pacira Pharmaceuticals developed the EXPAREL single administration drug shown to reduce postoperative pain and opioid use for up to 72 hours after surgery.

 

Endoscopic spine surgery. A select group of surgeons around the country are focused on endoscopic techniques for less invasive spine care. New technology and techniques are being developed around these types of technically complex procedures, such as Orthozon Technologies' Lumiere minimally invasive surgical retractor with powerful unobstructed fiber optic lighting, translucent retractor blades, full medial access and an expandable field of view. Orthozon announced new features available this year, including a hand-held LED light source with flexible fiber optic fibers and a larger size for more complex fusions.

 

The University of Colorado Hospital Spine Center is also currently working with KARL STORZ GmbH to develop a percutaneous lumbar endoscopic discectomy technique for treating herniated discs. The KARL STORZ product range includes percutaneous endoscopic cervical discectomy, percutaneous nucleotomy, foraminotomy and microsurgery.

 

Additionally, in November 2013, surgeons from the Desert Institute of Spine Care in Phoenix announced the development of the RISE spinal instrumentation for endoscopic TLIF with an 8 mm approach, and became the first to perform a mini-open procedure with the RISE expandable cage.

 

More Articles on Spine Surgery:
Scoliosis Procedures for the Growing Spine
The Robotic Difference: How New Technology Could Impact Spine
Minimally Invasive vs. Open Spine Surgery: Where the Field is Headed

 

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