Becker's Spine Review

32 DEVICES & IMPLANTS No Fusion, No Problem — How Coflex is Changing the Lumbar Spinal Stenosis Treatment Field By Megan Wood W ithin the lumbar degenerative market, lumbar spinal stenosis oen progresses in patients over time. While conservative care is the desired treatment, sometimes surgical intervention is necessary. LSS surgical intervention options include in- direct decompression; decompression alone; decompression plus fusion stabilization; and decompression plus coflex Interlaminar Sta- bilization. During a Paradigm Spine-sponsored work- shop, Hallett Mathews, MD, Paradigm Spine chief medical officer, provided an overview of the coflex Interlaminar Stabilization device, and how it is implanted aer a direct surgical decompression procedure. He delivered the presentation, titled "Introducing a Non-Fu- sion Alternative for Lumbar Spinal Stenosis in the ASC," at Becker's 15th Annual Spine, Orthopedic and Pain Management-Driven ASC Conference + e Future of Spine on June 24 in Chicago. A motion-preserving, neutral stabilization device, the coflex device loads on interlami- nar bone as opposed to spinous process bone. By leveraging this procedure, surgeons are able to see the nerve pathology through the laminotomy; complete the desired decom- pression; and add a non-fusion stabilization device. coflex is designed to preserve motion; reduce leg and back pain; maintain foraminal height; and preserve normal kinematics at the oper- ative and adjacent levels. "Surgeons now have the opportunity to stabilize a degenerative segment aer direct surgical decompression for lumbar spinal stenosis that does not in- volve a fusion procedure," explained Dr. Mathews. Prime candidates for the coflex device are those with leg and back pain caused by spinal stenosis who may benefit from a more exten- sive decompression, but may not have gross instability or require a fusion procedure. e device's indications are for one or two levels of the lumbar spine, L1 through L5. coflex evidence A class 3 device, the coflex device received premarket approval in October 2012. A five- year clinical trial compared coflex Interlami- nar Stabilization to pedicle screw fusion sur- gery for treating moderate to severe LSS. e 2016 study, published in International Journal of Spine Surgery, analyzed coflex safety, effica- cy and durability. coflex patients maintained significant improvement in visual analog scale leg and back pain. Decompression and interlaminar stabilization patients experi- enced significantly better SF-12 and Zurich Claudication Questionnaire scores during early follow-up, compared to decompression and fusion with pedicle screws patients. "is [study] not only addresses the steno- sis component, but it also helps both VAS back pain and leg pain that's sustained at five years," added Dr. Mathews. "So this treatment option is clinically durable and not a transi- tion to a bigger and more invasive fusion pro- cedure." e device's ability to maintain foraminal height, retain index level motion while pro- tecting the adjacent level kinematics creates a trifecta of care for spinal stenosis treatment. "You see some very substantial evidence to prove that this is a sustainable, durable, sta- bilization procedure that is not a fusion tech- nique, that involves motion-preserving stabi- lization aer a surgeon's decompression and it's certainly fit for the ASC setting, as well as multiple sites of service depending on medi- cal necessity," concluded Dr. Mathews. coflex in the outpatient setting During the workshop, omas Scully, MD, a neurosurgeon at Tucson, Ariz.-based North- west NeuroSpecialists, shared tips from his years of experience using the coflex device. 1. Dr. Scully emphasized the procedure is mainly a decompression, and surgeons must complete adequate decompressions in order for the device to properly work. 2. He recommended surgeons not be too ag- gressive with facet joint removal, as maintain- ing stability is critical. 3. Place the device as close to the dura as pos- sible, within 1 to 2 mm since it is an interlam- inar device, not a spinous process device. 4. When first using the coflex, Dr. Scully said many surgeons will undersize the device and with experience, surgeons will likely oversize it. Ideally, surgeons should shoot for 1 to 2 mm of facet separation. 5. Dr. Scully recommended using intraopera- tive X-ray to directly visualize the distraction. 6. Do not place the patient in kyphosis, but in neutral position. 7. Using the coflex requires more "carpentry work" with the spinous processes than other procedures, said Dr. Scully. If surgeons don't properly align the spinous processes, they will face laminar "moguls" that impair proper placement of the device in an anterior posi- tion. Dr. Scully shared three case studies of a 64-year-old male, 71-year-old male and 46-year-old female with varying symptoms. He performed a coflex Interlaminar Stabiliza- tion procedure on each patient, all of which experienced positive outcomes. "is is a happy cohort of patients," said Dr. Scully. coflex reimbursement CMS created a new Category 1 CPT code for interlaminar stabilization following a decom- pression surgery, effective Jan. 1, 2017. e code is CPT 22867: Insertion of interlaminar / interspinous process stabilization / distrac- tion device, without fusion, including image guidance when performed, with open de- compression, lumbar; single level. coflex is also indicated for two contiguous levels with using CPT 22868. It is listed in addition to the primary code and covers a second coflex procedure performed at an ad- ditional level. "e exciting thing about this code is that it is a bundled, Category 1 code, which denotes the highest level of clinical evidence," said Devon Billeter, Medical Science Liaison for Midwest/Central U.S. at Paradigm Spine. Medical Science Liaisons work with health- care providers to teach, train and advocate for the best path for the patient by leveraging clinical research, peer-reviewed articles and medical society publications to bring exper- tise to any setting of care.

• Cover