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42 Sign up for Becker's Orthopedic, Spine Business & Pain Management E-Weeklies at www.BeckersOrthopedicandSpine.com or call (800) 417-2035 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 Sys- tem for patients with SI joint dysfunction. The company received FDA clearance for the SIm- metry system in 2011. In March 2014, the Ameri- can 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 Spine- Guard'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 pri- or to a breach by analyzing the electrical conduc- tivity 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 re- ceived FDA clearance in August 2012. Minimally invasive deformity correction. Tech- nology 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 in- vasive procedures to treat adult patients with scolio- sis: lateral lumbar interbody fusion, direct lateral in- terbody fusion and rod placement with Medtronic's CD Horizon Longitudinal System. Some systems, such as SpineCraft's AIM Mini- mally 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-cer- vical pedicle fixation and non-pedicle fixation can also be used for scoliosis procedures. Less invasive procedures can lead to quicker re- covery times and lower pain scores, and device companies realize their importance. K2M's prod- ucts are also geared toward a minimally invasive approach for complex spinal procedures. This year the company celebrated its 10 th anniversary and currently has 57 spinal technologies and tech- niques. K2M set its sights on the future this year; the company submitted a draft registration state- ment on Jan. 25, 2014. Interspinous fixation. Interspinous fixation devices were designed and are currently being tested as al- ternatives to pedicle screw and rod constructs for interbody fusion procedures. Interspinous fixation systems are designed to increase motion when com- pared with fusion procedures. The FDA has cleared several devices, including the X-STOP Interspinous Process Decompression System and ZIP MIS Inter- spinous Fusion System from Aurora Spine. A two-year multicenter, randomized, controlled study comparing patients who received nonsurgi- cal 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 dis- tributors 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 bil- lion 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 Treat- ment System received FDA clearance in January as an implant-based solution for vertebral augmen- tation — 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 ex- ceeded 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 proce- dures are moving to the outpatient setting — in- cluding total joint replacements and some spinal procedures. The outpatient setting can improve quality and reduce cost of care, and as a result pa- tients, physicians and payers are now looking to am- bulatory surgery centers and hospital outpatient de- partments as the next frontier for spinal procedures. Device manufacturers have taken notice as well, and some are beginning to develop minimally in- vasive 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 ste- nosis decompression procedures. Richard Kube, MD, performed the first two-level coflex proce- dure 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 ad- dressing those issues. DePuy Synthes Select de- veloped a business model to bring outpatient or- thopedic 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 long hospital re- coveries. However, developments in anesthesia technique and shorter surgical time allow anes- thesiologists to control patients' pain postopera- tively with fewer side effects. Better pain management techniques also promote quicker ambulation and faster recovery. Pacira Phar- maceuticals developed the EXPAREL single admin- istration drug shown to reduce postoperative pain and opioid use for up to 72 hours after surgery. Endoscopic spine surgery. A select group of sur- geons around the country are focused on endo- scopic techniques for less invasive spine care. New technology and techniques are being developed around these types of technically complex pro- cedures, such as Orthozon Technologies' Lumiere minimally invasive surgical retractor with power- ful unobstructed fiber optic lighting, translucent retractor blades, full medial access and an ex- pandable 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 Cen- ter is also currently working with KARL STORZ GmbH to develop a percutaneous lumbar en- doscopic discectomy technique for treating her- niated discs. The KARL STORZ product range includes percutaneous endoscopic cervical dis- cectomy, percutaneous nucleotomy, foraminoto- my and microsurgery. Additionally, in November 2013, surgeons from the Desert Institute of Spine Care in Phoenix an- nounced the development of the RISE spinal in- strumentation for endoscopic TLIF with an 8 mm approach, and became the first to perform a mini- open procedure with the RISE expandable cage. n SpineCraft develops and manufactures spine surgery implant & instrument systems and surgical tools that offer solutions to improve quality of life for patients with complex spine problems, spine deformities, degenerative conditions, trauma injuries, back pain, and neck pain.