Globus Medical lands Anthem coverage win for Secure-C spinal implant

Globus Medical (NYSE:GMED) last week said it won a coverage decision for its Secure-C cervical spine implant from health insurance giant Anthem (NYSE:ANTM). Audubon, Pa.-based Globus said the decision means the device is covered by the major third-party payers in all 50 states. Anthem has more than 73 million lives under its coverage umbrella, according to Globus. The Secure-C device won pre-market approval from the FDA in 2012 and is is designed to restore normal movement to the neck in patients with disc problems that produce neck and arm pain. It consists of 2 cobalt-chrome endplates and a central polyethylene core that mimics the function of a healthy spinal disc. Globus said that its seven-year follow-up data show that patients implanted with the device showed statistically superior overall success results (86.3% vs. 70.0% of patients treated via anterior cervical discectomy &fusion); statistically superior composite FDA-defined overall success (79.2% vs. 63.6% for the ACDF comparator); a higher rate of patients showing at least 25% improvement in Neck Disability Index, a measure of pain and function (90.4% vs. 86.0%); a lower rate of subsequent surgery at the original treatment site (4.2% vs. 15.3%); and a lower rate of adjacent-level surgery (4.2% vs. 16.0%). “The long-term clinical results validate that Secure-C creates a significant improvement in patients’ lives over the long term, an important factor in expanding payer cover...
Source: Mass Device - Category: Medical Devices Authors: Tags: Orthopedics Spinal Wall Street Beat Anthem Inc. Globus Medical Reimbursement Source Type: news

Related Links:

This study compared the surgical outcomes of two surgical methods for treating multilevel cervical spondylotic myelopathy (MCSM) combined with cervical kyphotic deformity (CKD): (1) the ELTA method consisted of expansive open-door laminoplasty (EOLP) followed by three-segment anterior cervical discectomy fusion (ACDF), and (2) the LAPI method consisted of long-segment ACDF followed by long-level posterior instrumented fusion (PIF). Surgical treatment of CKD combined with MCSM remains challenging. Surgical considerations should include adequate spinal cord decompression and restoration of satisfactory cervical sagittal alig...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
Conclusion. An early self-directed HEP program was acceptable to patients and has the potential to be safely administered to patients immediately after ACDF. Benefits were noted for short-term neck pain and long-term opioid utilization. However, larger trials are needed to confirm safety with standardized and long-term radiograph assessment and treatment efficacy. Level of Evidence: 2
Source: Spine - Category: Orthopaedics Tags: RANDOMIZED TRIAL Source Type: research
Study Design. Retrospective comparative study. Objective. The purpose of this study was to investigate whether preoperative depressive symptoms, measured by mental component score of the Short Form-12 survey (MCS-12), influence patient-reported outcome measurements (PROMs) following an anterior cervical discectomy and fusion (ACDF) surgery for cervical degeneration. Summary of Background Data. There is a paucity of literature regarding preoperative depression and PROMs following ACDF surgery for cervical degenerative disease. Methods. Patients who underwent an ACDF for degenerative cervical pathology were identi...
Source: Spine - Category: Orthopaedics Tags: HEALTH SERVICES RESEARCH Source Type: research
AbstractRecently, a bioactive glass ceramic (BGC) has been developed for use as intervertebral cages for anterior cervical discectomy and fusion (ACDF). However, the effectiveness and safety of BGC cages remain to be evaluated. We completed a retrospective comparison of the radiological and clinical outcomes of 36 patients (52 levels) who underwent ACDF with a BGC cage and 35 patients (54 levels) using allograft bone. The following variables were compared between the two groups: the visual analog (VAS) neck and arm pain score and the neck disability index (NDI), measured before surgery and 1  year after; the change in...
Source: Neurosurgical Review - Category: Neurosurgery Source Type: research
Conclusions: Patients undergoing a primary 1–3 level ACDF experience significant improvements in PROMIS PF scores at 12-week and 6-month follow-up. Furthermore, PROMIS PF exhibits strong correlations to NDI and SF-12 at all preoperative and postoperative time points. These results suggest that PROMIS PF accurately measures PF and may be used in lieu of legacy PF instruments for patients undergoing ACDF.
Source: Journal of Spinal Disorders and Techniques - Category: Surgery Tags: Primary Research Source Type: research
Conclusions: Our study suggests that tobacco use does not influence inpatient pain scores, narcotic consumption, and improvements in PROs following ACDF. As such, tobacco users and nonusers should receive similar postoperative pain management protocols following surgery. Level of Evidence: Level III.
Source: Journal of Spinal Disorders and Techniques - Category: Surgery Tags: Primary Research Source Type: research
Conclusions: Although PAM has been associated with better postoperative recovery in lumbar spine patients and other orthopedic surgeries, our investigation suggests that preoperative PAM assessments are not an effective method to predict postoperative outcomes following an ACDF.
Source: Journal of Spinal Disorders and Techniques - Category: Surgery Tags: Primary Research Source Type: research
Conclusion. The DASH is a valid and responsive PRO measure to evaluate disabling upper extremity involvement in patients undergoing cervical spine surgery. Level of Evidence: 3
Source: Spine - Category: Orthopaedics Tags: HEALTH SERVICES RESEARCH Source Type: research
The objective of this article is to assess the effect of screw migration and fracture associated with anterior cervical plating on long-term radiographic and clinical outcomes. Background Data: Screw migration and breakage detected after anterior cervical discectomy/corpectomy and fusion with plating may cause various implant-related complications and reduce solid fusion rate. However, little is known about their long-term prognosis. Materials and Methods: Medical records and radiographic data of 248 consecutive patients who underwent anterior cervical discectomy and fusion or anterior cervical corpectomy and fusion ...
Source: Journal of Spinal Disorders and Techniques - Category: Surgery Tags: PRIMARY RESEARCH Source Type: research
Conclusions: In this prospective, observational study, postoperative increase in grip and pinch strength demonstrated an association with improvement of pain and disability of the neck and overall quality of health regardless of the presence of cervical myelopathy. Preoperative grip strength weakness was found to be predictive of postoperative grip strength deficiency after ACDF. Our investigation suggests the recovery of hand function may be correlated with improvement of PROs after ACDF.
Source: Journal of Spinal Disorders and Techniques - Category: Surgery Tags: PRIMARY RESEARCH Source Type: research
More News: Back Pain | Cervical Discectomy | Cobalt | Disability | Health Insurance | Insurance | Orthopaedics | Pain | Statistics