NASS News: Zimmer Biomet Spine Announces Four Podium Presentations Validating Mobi-C Cervical Disc

Zimmer Biomet Holdings Inc., a global leader in musculoskeletal healthcare, announced that four studies supporting the efficacy of the Ccmpany’s Mobi-C will be presented at the 2017 North American Spine Society (NASS) Annual Meeting, held this week in Orlando, Fla. Mobi-C Cervical Disc is a leading option for cervical total disc replacement (cTDR) designed to maintain patient range of motion post-surgery.
 
In addition to the presentations on Mobi-C, Zimmer Biomet Spine will be featuring the newly launched Vitality+ and Vital Spinal Fixation Systems at Booth No. 505. Vitality+ consists of Vitality+ POWER for simple, controlled pedicle preparation and pedicle screw insertion; Vitality+ HOOKS with an extensive array of additional fixation options; and Vitality+ PSO for optimal pedicle subtraction osteotomy and vertebral column resection procedures. In addition, the Vital Spinal Fixation System, an intuitive and optimized two-kit degenerative pedicle screw system, will also be on display.
 
Joe Ross, General Manager of Global Spine, commented, “We are pleased to demonstrate our latest findings at the largest gathering of spine surgeons in North America, and are particularly excited to have Mobi-C featured in several podium presentations. In addition, we are honored that our Mobi-C presentation on the clinical implications of heterotopic ossification (HO) after seven years received the NASS Section on Spine Motion Technology Best Paper rating. This study demonstrated cTDR clinical outcomes after seven years were unchanged with clinically relevant HO, which marks a significant validation of our total disc replacement technology’s ability to maintain positive patient outcomes long-term.”
 
Details of the presentations follow:
 
Podium Presentation: Long-Term Clinical Results of Cervical Total Disc Replacement with a Self-Adjusting Mobile Core Prosthesis after Ten-Year Follow-Up
Session:                               Section on Spine Motion Technology Abstract Presentations
Room:                                   WF1
Date and Time: Oct. 26, 3:58 p.m. – 4:04 p.m.
Presenting Author:         Tierry Dufour, M.D.
Institutions:                        Institut Parisien du Dos – Spine Center of Paris, Paris, France
Product Focus:  Mobi-C
 
The observational, prospective study is ongoing at eight French centers and enrolling 384 patients treated with cTDR with Mobi-C for symptomatic degenerative disc disease. At the time the database was closed, the 10-year follow-up assessments were available for 84 patients. For these 84 patients, overall long-term outcomes showed that TDR with Mobi-C demonstrated favorable clinical outcomes and a very low adjacent disc disease surgery rate, showing that Mobi-C is both safe and effective.
 
Podium Presentation: Item-specific Improvements in Neck Disability after TDR or ACDF: A Post-hoc Analysis of Self-reported Outcomes from a Prospective Clinical Trial
Session:                               Section on Spine Motion Technology Abstract
Date and Time: Oct. 26, 4:34 p.m. – 4:40 p.m.
Presenting Author:         Kris Radcliff, M.D.
Institutions:                        Rothman Institute, Thomas Jefferson University, Egg Harbor, N.J.
Product Focus:  Mobi-C
 
The prospective, randomized, multicenter, U.S. FDA clinical trial was a post-hoc analysis comparing TDR with Mobi-C to anterior cervical discectomy and fusion (ACDF). The study evaluated patients based on the Neck Disability Index (NDI) post-surgery. Researchers found TDR resulted in significantly greater improvement as compared to ACDF, in nine of 10 NDI items, and these differences were maintained for five years. This study was nominated for the NASS Value Award, which was created in 2011 to foster and recognize efforts to define value in spine care. The program is open to podium presentations being featured at NASS.
 
Podium Presentation: Outcomes after Motion-restricting Heterotopic Ossification in Patients with Cervical Total Disc Replacement: How do they Compare to ACDF?
Session:                               Section on Spine Motion Technology Abstract
Date and Time: Oct. 26, 4:40 p.m. – 4:46 p.m.
Presenting Author:         Hyun Bae, M.D.
Institutions:                        Cedars Sinai Medical Center, Los Angeles, Calif.
Product Focus:  Mobi-C
 
The post-hoc analysis of TDR patients included those with a Grade 4 heterotopic ossification (HO), compared to a matched group of patients with ACDF and mobile TDR. The 599 patients were part of a randomized, multicenter clinical trial to compare the safety and effectiveness of TDR with Mobi-C after the onset of motion-restricting HO to ACDF for the treatment of cervical degenerative disc disease. Patients with motion-restricting HO had similar or better patient-reported outcomes and delayed progression of adjacent level degeneration compared to ACDF. In addition, subsequent surgery rates after HO-induced fusion were significantly lower than ACDF.
 
Podium Presentation: Clinical Implications and Risk Factors of Heterotopic Ossification after Cervical Total Disc Replacement at Seven Years
Session:                               Section on Spine Motion Technology Abstract
Date and Time: Oct. 26, 4:46 – 4:52 p.m.
Presenting Author:         Pierce Nunley, M.D.
Institutions:                        Louisiana Spine Institute, Shreveport, La.
Product Focus:  Mobi-C
 
The post-hoc, multiple phase analysis was designed to report HO prevalence, progression, clinical implications and risk factors following cervical total disc replacement surgery with Mobi-C. The study is the largest to date to report HO rates, as well as related outcomes and risk factors. After seven years, clinical outcomes were unchanged with clinically relevant HO. Based on the data, researchers found that clinically relevant HO should instead be described as motion-restricting HO. This presentation received the Section on Spine Motion Technology Best Paper rating.
 
Mobi-C Cervical Disc
Mobi-C is the first cervical disc prosthesis approved by the U.S. Food and Drug Administration for reconstruction of the cervical disc at both one and two levels to treat severe pain in the neck or arm caused by various spine disorders or injuries. Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling to accommodate vertebral anchorage such as screws or keels. The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.
 
Founded in 1927 and headquartered in Warsaw, Ind., Zimmer Biomet is a global leader in musculoskeletal healthcare. The company designs, manufactures and markets orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; office-based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products. Zimmer Biomet has operations in more than 25 countries around the world and sell products in more than 100 countries.