4 Spine Technology Highlights from NASS 2019

Technology Highlights from the 34th Annual Meeting of the North American Spine Society.

Chicago was the destination for the 34th Annual Meeting of the North American Spine Society (NASS 2019). Spine care professionals convened to hear the latest research, touch and try innovative technologies, take advantage of a wide range of educational programs, and even de-stress with therapy dogs. As in past years, the exhibition hall was the central meeting place, and SpineUniverse thanks EOS imaging, Relievant Medsystems, Simplify Medical, and Zimmer Biomet for taking time to speak with us.

modern spine physician contemplating technologyInnovative spine technologies were a focus for spine care professionals in the exhibition hall at the North American Spine Society's 34th Annual Meeting. Photo Source: iStock.com.

EOS imaging—An Orthopaedic Solutions Company

EOS imaging, well known as an innovative medical imaging company, has grown their portfolio as a global company offering orthopaedic solutions on a broad scale. “Best-in-class imaging, use of EOS images to drive 3D modeling of the patient’s musculoskeletal system, online 3D surgical planning for surgeons, and now a link to the OR,” is how Mike Lobinsky, CEO, summed it up.

The EOS system offers patients and surgeons low dose, full body, weight-bearing imaging in about 20 seconds. Their Micro Dose acquisition protocol is particularly advantageous to pediatric scoliosis patients whose follow-up care includes many imaging studies over an extended time period. “Using the Micro Dose protocol, radiation is 7 times lower than our standard low-dose exam that is already a 50% lower dose than a digital x-ray,” stated Lukas Vancura, EOS Advanced Orthopedics Solutions (AOS) Director.

AOS creates tools to help surgeons bring 3D modeling into their practice for preoperative assessment, surgical planning, postoperative evaluation and follow-up. Surgical planning solutions include spineEOS, hipEOS and kneeEOS. The company’s 3D Services support using EOS images and EOSapps—the online portal that enables surgeons to upload patients’ 2D images to receive 3D models within 24 hours. The next dimension in the company’s portfolio is EOSlink™, which seamlessly enables patient-specific EOSapps into the operating room via advanced surgical technologies.

Source
EOS imaging to Showcase Breakthrough Spine Solutions at North American Spine Society (NASS) 34th Annual Meeting. Press Release. EOS imaging. September 25, 2019.

Relievant Medsystems’ Intracept® Procedure Stands on Level 1 Evidence—Twice

SpineUniverse spoke with Ray Baker, MD, Chief Medical Officer for Relievant Medsystems about their Intracept® procedure—a minimally invasive outpatient treatment that targets the basivertebral nerve (BVN) to relieve vertebrogenic chronic low back pain. The procedure is implant-free, preserves spinal structure, and provides durable pain relief supported by two Level 1 randomized, controlled multi-center clinical studies. Several years of podium presence has broadened physician awareness of the BVN, its relationship with vertebrogenic low back pain, and the Intracept Intraosseous Nerve Ablation System.

Regarding the INTRACEPT Study1 and SMART Trial,2 Dr. Baker pointed out, “Two positive Level 1 studies are an uncommon occurrence in the spinal device space, especially given that the SMART trial used a sham control. The SMART Trial also demonstrated maintenance of outcomes and a significant reduction in opioid usage through 2 years.” He indicated the INTRACEPT Study was stopped early due to superiority compared to standard care (nonsurgical care) as all primary and secondary endpoints were highly significant compared to standard care. Furthermore, responder rates were similar across the INTRACEPT Study and SMART Trial, demonstrating the consistency of patient response. These results were further bolstered by a case series published in May by Truumees et al, in which even greater improvements in ODI and VAS were reported in a typical spine practice setting.

Unlike other spinal ablation procedures that target facets or the disc, Intracept targets the basivertebral nerve—the major source of innervation within the vertebra—which transmits vertebrogenic pain signals from damaged endplates. The end result of endplate damage can be seen on routine MRI as Modic changes, an objective biomarker that identifies patients with vertebrogenic pain. Unfortunately, many patients with vertebrogenic pain have been misdiagnosed as having disc pain.

Intracept is a unilateral, transpedicular procedure performed under fluoroscopic guidance. An introducer is advanced through the pedicle; a channel is created to the center of the vertebral body; the Intracept RF probe is then positioned at the base of the BVN. Radiofrequency energy is then utilized to ablate the BVN, preventing it from transmitting vertebrogenic pain signals.

Relievant Medsystems wants to educate physicians and patients using two simple messages: (1) Vertebrogenic pain is an important source of chronic low back pain, and (2) The Intracept procedure is a scientifically validated and durable treatment for the 15% of patients suffering from vertebrogenic low back pain.

References
1. Khalil J, Smuck M, Koreckij T, Keel J, Beall D, Goodman B, et al. A prospective, randomized, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2019;19(10):1620-1632. doi: https://doi.org/10.1016/j.spinee.2019.05.598.

2. Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 2-year results from a prospective randomized double-blind sham-controlled multicenter study. Int J Spine Surg. 2019;13(2):110-119. doi:10.14444/6015.

Simplify Medical Sets a Clinically High Bar

SpineUniverse spoke with David Hovda during the 34th Annual Meeting of the North American Spine Society about the Simplify® Disc; an investigational device for cervical arthroplasty. Mr. Hovda is Simplify Medical’s President and CEO. “The early clinical results we’re seeing are promising, but we’re not done with our studies and can’t make any claims,” he stated.

The Simplify Disc is based on a predecessor disc (Kineflex|C) with over 5 years of clinical data, which showed superiority to ACDF and significant improvement in neck disability index during follow-up through 5 years. The Simplify Disc includes a 4mm option, which is unique to our product line and is designed for closer matching to a patient’s anatomy. “We think we’re on the right track with the lower height as an option,” stated Mr. Hovda. Furthermore, the company has focused on streamlining device implantation.

The Simplify Disc is the only cervical artificial disc that is designed for MRI compatibility.* “Many of the approved cervical discs have nickel in the endplates; the Simplify Disc does not,” Mr. Hovda commented. The mobile bearing disc is engineered with a ceramic core and titanium coated PEEK endplates, so there is no metal wear from the articulation.

Mr. Hovda said, “We’re very thankful for our surgeon support and their positive feedback—we’ve treated 200 patients in our two-level trial and 166 patients in our one-level trial, and we are using historical fusion controls in each study.” It is a lot of patients, clinical follow-ups, and hard work on the part of investigators and their patients, but it should be. It’s a lifetime articulating implant, and the bar for approval should be high,” Mr. Hovda stated in his closing remarks.

Source
*Simplify Disc®, The Difference is Clear. MR Conditional per ASTM 2503-13, 2019.

Zimmer Biomet Adds Healthcare Value Through Collaboration

This has been a remarkable year for Zimmer Biomet considering the U.S. Food and Drug Administration (FDA) clearance of the ROSA® ONE Spine System1 and the FDA approval of The Tether™.2 SpineUniverse took the opportunity to speak with Jim Cloar during the 34th Annual Meeting of the North American Spine Society. Mr. Cloar is President, Global Spine for Zimmer Biomet. Mr. Cloar made the point that connecting with innovative surgeons is a positive force behind Zimmer Biomet’s product line and platform technologies for minimally invasive and complex spine surgeries.

The ROSA ONE Spine is a robotic and surgical navigation system with dynamic tracking that allows its multi-functional robot to move with the patient. It shares the same platform as ROSA ONE Brain and ROSA Knee. These systems are designed to “deliver care and collect data,” Mr. Cloar stated.

The WalterLorenz® Surgical Assist Arm also is representative of a platform technology described as, “A bionic device that transforms your operating room.”3 The table-mounted WalterLorenz Surgical Assist Arm gives the surgeon single-handed button powered instrument control that minimizes “drift” and mimics a human surgical assistant’s motions that doesn’t fatigue. Also—it must be mentioned here the Walter technology received the 2019 Bronze Award in Radiological, Imaging, and Electromechanical Devices from the Medical Design Excellence Awards for it value to improve the quality of healthcare.

The mymobility4 mobile application is another type of collaborative healthcare effort between Apple and Zimmer Biomet. In fact, Zimmer Biomet is one of only 4 companies Apple has chosen to partner with to improve patient engagement and outcomes. The mymobility app uses iPhone® and Apple Watch® to provide pre- and postoperative educational information to empower patients to take an active role in their recovery. The app continuously collects different types of patient data that is remotely transferred to the surgeon’s dashboard. In short, mymobility helps maintain communication between the surgeon and patient.

References
1. Zimmer Biomet Receives FDA Clearance of ROSA® ONE Spine System for Robotically-Assisted Surgeries. Press Release. March 25, 2019.

2. The Tether™ - Vertebral Body Tethering System - H190005. U.S. Food and Drug Administration. August 16, 2019.

3. Meet the WalterLorenz® Surgical Assist Arm. Zimmer Biomet. https://www.walterlorenzarm.com.

4. mymobility with Apple Watch. Zimmer Biomet. https://www.zbmymobility.com.

Updated on: 10/24/19
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