ACDF

Aurora Spine Corporation Celebrates Second Anniversary of Initial Implantation of the World’s First Bone Density Matched DEXA-C Cervical Interbody Fusion Device

Retrieved on: 
Wednesday, March 20, 2024
ASG, ACDF, Institutional review board, MRI, Patent, Patient, United, Degenerative disc disease, DEXA, DDD, Neurosurgery, Bone density, Spine, Trial of the century, IRB

The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density.

Key Points: 
  • The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density.
  • I am able to confidently offer multilevel anterior fusions to patients who likely could not have benefitted from other existing implants because of their bone density.
  • In June 2023, Aurora announced that the first patient has been enrolled for its multicenter study of DEXA-CTM Cervical Interbody System.
  • Preliminarily, we have seen both in radiographs and surgical exploration that patients have incipient bone fusion by 90 days after surgery.

Orthofix Announces Publication in The Spine Journal of Five-Year Data for the M6-C Artificial Cervical Disc

Retrieved on: 
Wednesday, November 29, 2023
Biotechnology, Physical Therapy, Surgery, Health, FDA, Medical Devices, Clinical Trials, Other Health, Principal, Food and Drug Administration, Neck, SSI, Orthopedic surgery, Safety, Food, Radiculopathy, Spine, Clinical trial, Patient, Multimedia, ACDF, The Spine Journal, IDE, SAE, Trial of the century, Rush University Medical Center, Pain, Medical device

(NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the publication of the five-year results from the U.S. clinical study comparing the M6-C™ artificial cervical disc with anterior cervical discectomy and fusion (ACDF).

Key Points: 
  • (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the publication of the five-year results from the U.S. clinical study comparing the M6-C™ artificial cervical disc with anterior cervical discectomy and fusion (ACDF).
  • Published in The Spine Journal , patients treated with the M6-C disc demonstrated superior clinical success at 60 months compared to ACDF patients.
  • View the full release here: https://www.businesswire.com/news/home/20231129606400/en/
    The Orthofix M6-C™ artificial cervical disc is a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration.
  • “Artificial cervical disc replacement is becoming the gold standard of care for indicated patients who may otherwise be facing cervical disc fusion.

Providence Medical Technology Announces New Publication Demonstrating High Fusion Rates and Successful Outcomes in Previously Failed Cervical Fusion Patients

Retrieved on: 
Thursday, December 7, 2023
Risk factor, Neck, Research, FFS, Orthopedic surgery, Duke University, Borat Subsequent Moviefilm, FUSE, Surgeon, Immobilization, Patient, Journal, ACDF, PCF, Nonunion, Success, Pain, Bleeding, Risk, Journal of Clinical Neuroscience, Hospital, Diabetes, Motion, Smoking, Birth control, Dentistry, Pharmaceutical industry, C7, C3, Neurosurgery

PLEASANTON, Calif., Dec. 7, 2023 /PRNewswire/ -- Providence Medical Technology, Inc., a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, today announced a new publication in the Journal of Clinical Neuroscience. Dr. Michael M. Haglund and colleagues authored the publication on the long-term outcomes of patients undergoing tissue-sparing Posterior Cervical Fusion (PCF) to revise a 1-level pseudarthrosis following a failed Anterior Cervical Discectomy and Fusion (ACDF).

Key Points: 
  • Dr. Michael M. Haglund and colleagues authored the publication on the long-term outcomes of patients undergoing tissue-sparing Posterior Cervical Fusion (PCF) to revise a 1-level pseudarthrosis following a failed Anterior Cervical Discectomy and Fusion (ACDF).
  • There are over 300,000 cervical fusion procedures performed each year, with over 40% involving patients with some form of risk factors for nonunion.
  • Our tissue-sparing posterior fusion technology is a great option to treat these patients, as is well demonstrated in this study.
  • Providence Medical Technology devices have been used to treat over 20,000 patients and are currently available in over 2,500 hospitals in the United States.

DISC Surgery Center at Newport Beach Now Enrolling Patients in Clinical Study on Artificial Disc Replacement

Retrieved on: 
Tuesday, November 28, 2023
Health, Research, Safety, Patient, DISC, Motion, Radiculopathy, ACDF, Trial of the century, FDA, Nursing, DRS

NEWPORT BEACH, Calif., Nov. 28, 2023 /PRNewswire/ --Committed to supporting research vital to the field of spinal care, DISC Surgery Center at Newport Beach ("DISC") has announced its participation in a clinical study on artificial disc replacement and is now enrolling qualified patients. Candidates may include patients between the ages of 18 and 75 who have been told they need cervical (neck) surgery at two consecutive levels (among other requirements).

Key Points: 
  • NEWPORT BEACH, Calif., Nov. 28, 2023 /PRNewswire/ --Committed to supporting research vital to the field of spinal care, DISC Surgery Center at Newport Beach ("DISC") has announced its participation in a clinical study on artificial disc replacement and is now enrolling qualified patients.
  • Artificial disc replacement surgery is very similar to ACDF surgery.
  • However, when the deteriorated disc is removed for disc replacement, the space in between the vertebrae is filled with a specialized implant called an artificial disc, instead of a bone graft.
  • "The DISC Surgery Center at Newport Beach has put in over 3,000 cervical artificial discs since 2018, and we are well-versed in the surgery's motion-preservation qualities," said Dr. Mesiwala.

Five-Year Study Outcomes of the NuVasive Simplify Cervical Disc were Presented at the North American Spine Society 38th Annual Meeting

Retrieved on: 
Tuesday, October 24, 2023
Simplification, VAS, North American Spine Society, NYSE, Globus Medical, ACDF, NASS, Spine, Visual analogue scale, Contraindication, Annual general meeting, Overalls, NDI, Motion, Birth control

AUDUBON, Pa., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, presented five-year outcomes from the NuVasive Simplify Cervical Disc study at the North American Spine Society (NASS) 38th Annual Meeting.

Key Points: 
  • AUDUBON, Pa., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, presented five-year outcomes from the NuVasive Simplify Cervical Disc study at the North American Spine Society (NASS) 38th Annual Meeting.
  • The study demonstrates positive, long-term clinical outcomes, a high rate of overall composite success at 60 months, and statistical superiority to anterior cervical discectomy fusion (ACDF) procedural outcomes.
  • “Having clinically backed, long-term data for the Simplify Cervical Disc validates the promising clinical data we saw Simplify having at the two-year mark,” said Kyle Malone, senior vice president, Scientific Affairs of Globus Medical.
  • Dr. Pierce Nunley of the Spine Institute of Louisiana expressed his enthusiasm about the durability of the positive outcomes observed at 24 months.

MiRus Announces FDA 510(k) Clearance for Molybdenum-Rhenium (MoRe®) Low Profile Anterior Cervical and Lateral Lumbar Plating Systems

Retrieved on: 
Wednesday, October 18, 2023
FDA, ACP, MD, Spine, Vertebra, Catherine Disher, Dysphagia, Patient, ACDF, Risk, Surgeon, Integration, Rhenium, Birth control

ATLANTA, Oct. 18, 2023 /PRNewswire/ -- MiRus® announced  that it has received FDA 510(k) clearance of the CYGNUS™ MoRe® Anterior Cervical Plate and MiRus® 3DR™ Lateral Lumbar Interbody Fusion System with Integrated MoRe®  plate fixation, both being the narrowest and thinnest plating system amongst all plates on the global spine market.

Key Points: 
  • ATLANTA, Oct. 18, 2023 /PRNewswire/ -- MiRus® announced  that it has received FDA 510(k) clearance of the CYGNUS™ MoRe® Anterior Cervical Plate and MiRus® 3DR™ Lateral Lumbar Interbody Fusion System with Integrated MoRe®  plate fixation, both being the narrowest and thinnest plating system amongst all plates on the global spine market.
  • MoRe®, a proprietary molybdenum rhenium superalloy for medical implants, provides an unprecedented combination of strength, ductility, durability, and biological safety.
  • The proprietary molybdenum-rhenium alloy used in the Integrated MoRe® lateral  plate allows for a dramatically smaller footprint of tapered 2mm thickness, without sacrificing performance.
  • The Integrated MoRe® Lateral  Plate was awarded the 2023  Spine Technology Award for its clinical relevance, clinical problem solving and  likelihood of improving patient outcomes.

Cerapedics Reinforces Commitment to Level 1 Evidence with Long-Term Results from Six-Year Pivotal IDE Cervical Study Demonstrating 98.6% Spine Fusion Rates in Patients Treated With i-FACTOR®

Retrieved on: 
Tuesday, October 17, 2023
Carle Illinois College of Medicine, Anterior cervical discectomy and fusion, Standard of care, ACDF, Insurance, Safety, FDA, IDE, Publication, Level 1, Patient, Class, Pharmaceutical industry, Neurosurgery, Spine

Published data demonstrated fusion rates in single-level Anterior Cervical Discectomy and Fusion (ACDF) of 98.6% after six years in patients treated with i-FACTOR and reinforces Cerapedics' commitment to capturing long-term clinical evidence.

Key Points: 
  • Published data demonstrated fusion rates in single-level Anterior Cervical Discectomy and Fusion (ACDF) of 98.6% after six years in patients treated with i-FACTOR and reinforces Cerapedics' commitment to capturing long-term clinical evidence.
  • In particular, the results further support the safety and efficacy profile of i-FACTOR at one and two years, as published in Spine and Neurosurgery.
  • i-FACTOR has proven statistical superiority vs. local autograft in overall success* at one and two-year endpoints for single-level ACDF.
  • "Combined with the IDE study results, these data add to the clinical understanding of i-FACTOR's efficacy and safety.

SURE Retractors Inc announces the first 2 cases with its new A/P Sterile Cervical Retractor System

Retrieved on: 
Tuesday, October 17, 2023
Hospital, ASC, Ambulatory Surgery Center Association, SURE, MD, ACDF, Radiation, Howard University Hospital, SUNRISE, Sterilization, Trauma, Neurosurgery, NEWS, Central cord syndrome, Howard University, Physician, AP, OR, Security (finance), Birth control, D.C

The retractor comes in a sterile pack, which the staff loved, and has everything you need in one small box.

Key Points: 
  • The retractor comes in a sterile pack, which the staff loved, and has everything you need in one small box.
  • I will continue using the SURE retractor on all my future cervical cases and believe this will become the standard of care for retractors moving forward.”
    SURE radiolucent retractors are single-use, surgery-ready, sterile-packed, and easy to use.
  • I’ve previously used SURE retractors for posterior cervical, thoracic, and lumbar procedures as well as ACDF.
  • I’m happy to use the SURE retractor with any future cases without reservation.”
    With SURE Retractors you can maximize your operational and logistical efficiency, which also helps more cases to be planned with certainty.

ZimVie Announces FDA Approval to Launch Mobi-C® Hybrid Study

Retrieved on: 
Tuesday, September 26, 2023
Surgeon, University, C7, University of California, Davis, ACDF, CDA, C3, Motion, Professor, Patient, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Medical device, Pharmaceutical industry

Surgeons have implanted over 200,000 Mobi-C implants for cervical disc replacement at one level or two contiguous levels since 2004.

Key Points: 
  • Surgeons have implanted over 200,000 Mobi-C implants for cervical disc replacement at one level or two contiguous levels since 2004.
  • In 2013, Mobi-C became the first cervical disc approved for one and two levels by the FDA and remains the market-leading device for cervical disc replacement.
  • Kee D. Kim, M.D., Professor and Chief of Spinal Neurosurgery at the University of California, Davis, and one of the investigators in the study, shared, “The FDA approval of the IDE application will allow us to move forward with this important study.
  • Good clinical data is an important step in broadening the approved indications for cervical disc replacement in hybrid constructs with fusion at an adjacent level.

It’s Official: Studies Find Worker’s Comp Patients Fare Worse After Spine Surgery Than Other Patients

Retrieved on: 
Wednesday, September 6, 2023
Surgery, Health, Professional Services, Health Insurance, Human Resources, Spine, Smoker, Depression, Journal of Neurosurgery, Anxiety, Life, Quality of life, ACDF, Research, Brain, Patient, Harvard University, Pain, Back pain, Mevalonate pathway, Overweight, Decompression, Trauma, Mental health, HMT, Conference, QOD, Injury, Pharmaceutical industry, Medical device, Nursing

Two studies in the peer-reviewed Journal of Neurosurgery: Spine confirm what has long been suspected: worker’s compensation (WC) patients undergoing lumbar spine surgery fare worse post-surgery than other patients undergoing the same procedures.

Key Points: 
  • Two studies in the peer-reviewed Journal of Neurosurgery: Spine confirm what has long been suspected: worker’s compensation (WC) patients undergoing lumbar spine surgery fare worse post-surgery than other patients undergoing the same procedures.
  • One-year postoperative improvements, return-to-work rates and satisfaction were all significantly lower for workers’ compensation compared with non-workers compensation patients, even though workers’ compensation patients had fewer comorbidities and were younger.
  • It also found that worker’s compensation patients were significantly more likely to experience greater pain and residual disability, as well as a delayed return to work, than other patients.
  • Vx® Therapy equips patients to resume their normal activities of daily living sooner and with minimal disruption.