ACDF

CoreLink Announces FDA Clearance of F3D-C2 Stand-alone Cervical Spine System

Retrieved on: 
Tuesday, June 30, 2020
Biotechnology, FDA, Surgery, Medical devices, Health, Medical Subject Headings, Medical classification, Medical specialties, Neurosurgery, Anterior cervical discectomy and fusion, Discectomy, ACDF, Cervical vertebrae, Vertebral column

CoreLink, LLC , a leading designer and manufacturer of spinal implant systems, today announced the commercial launch and 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the F3D-C2 Stand-alone Cervical System .

Key Points: 
  • CoreLink, LLC , a leading designer and manufacturer of spinal implant systems, today announced the commercial launch and 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the F3D-C2 Stand-alone Cervical System .
  • View the full release here: https://www.businesswire.com/news/home/20200630005144/en/
    The F3D-C2 Stand-alone Cervical Spine System features an additively manufactured spacer with two bone screw anchors secured by a locking mechanism printed within the cage.
  • Stand-alone cervical devices eliminate the need for a supplemental fixation plate, making anterior cervical discectomy and fusion (ACDF) procedures easier and faster to complete.
  • The F3D-C2 Stand-alone Cervical System features the only 3D printed spine technology with both a trabecular structure and directional support lattices designed to allow for fusion throughout the entire implant, said Jay Bartling, CEO of CoreLink.

Providence Medical Technology Announces First Patient Enrollment in the "FUSE" IDE Clinical Study

Retrieved on: 
Monday, June 15, 2020
Medical specialties, Medicine, Degenerative disc disease, ACDF, Cervical vertebrae, Clinical medicine, Neurosurgical procedures, Geriatrics, Spinal cord disorders, RTT, Anterior cervical discectomy and fusion

The study is designed to demonstrate that Circumferential Cervical Fusion (CCF) achieves superior clinical outcomes versus ACDF for the treatment of 3-level cervical degenerative disc disease.

Key Points: 
  • The study is designed to demonstrate that Circumferential Cervical Fusion (CCF) achieves superior clinical outcomes versus ACDF for the treatment of 3-level cervical degenerative disc disease.
  • Providence CEO & Co-founder, Jeff Smith, explained the importance of the FUSE Study: "Our purpose at Providence is to improve clinical outcomes for high-risk patients and prevent surgical failures of the cervical spine.
  • The FUSE Study is an important next step towards that goal, and we are grateful for the support and dedication of our clinical investigators."
  • Providence Medical Technology, Inc. is a privately held medical device company focused on innovative and tissue-sparing surgical solutions for cervical spine surgery.

RTI Surgical® Announces Commercial Launch of the CervAlign® Anterior Cervical Plate System

Retrieved on: 
Tuesday, September 24, 2019
Medical specialties, Surgery, Medical classification, Anterior cervical discectomy and fusion, Irregular bones, Skeletal system, Vertebrate anatomy, ACDF, Discectomy, Cervical vertebrae, Vertebral column, Draft:Xenco Medical

DEERFIELD, Ill., Sept. 24, 2019 (GLOBE NEWSWIRE) -- RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced the full commercial launch of the CervAlign Anterior Cervical Plate (ACP) System to add to the growth of its Established Therapies spine portfolio.

Key Points: 
  • DEERFIELD, Ill., Sept. 24, 2019 (GLOBE NEWSWIRE) -- RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced the full commercial launch of the CervAlign Anterior Cervical Plate (ACP) System to add to the growth of its Established Therapies spine portfolio.
  • The CervAlign ACP System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending and axial rotation with strength and stiffness in the cervical spine (C2-C7).
  • The system includes implants of various plate and screw sizes to accommodate varying patient anatomies.
  • Additionally, using the Fortilink-C Interbody Fusion (IBF) System with TETRAfuse 3D Technology and ViBone Viable Bone Matrix with the CervAlign ACP provides surgeons a complete anterior cervical discectomy and fusion (ACDF) solution.

NuVasive Expands Cervical Advanced Materials Science™ Portfolio with Launch of Porous Titanium Implant

Retrieved on: 
Thursday, September 5, 2019
Medical specialties, Surgery, Medicine, Neurosurgical procedures, Anterior cervical discectomy and fusion, NuVasive, Neurosurgery, ACDF, Discectomy, Draft:Xenco Medical, Xenco Medical

The availability of Modulus Cervical expands the Company's Advanced Materials Science(AMS) portfolio to include both Porous PEEKand porous titanium offerings for anterior cervical discectomy and fusion (ACDF) techniques, a commonly performed surgery to address cervical disc degeneration or spinal instability.

Key Points: 
  • The availability of Modulus Cervical expands the Company's Advanced Materials Science(AMS) portfolio to include both Porous PEEKand porous titanium offerings for anterior cervical discectomy and fusion (ACDF) techniques, a commonly performed surgery to address cervical disc degeneration or spinal instability.
  • NuVasive's Modulus offerings are part of the Company's AMS portfolio that represent the future of porous implant technologies.
  • "These characteristics, combined with the implant's porous surface technology, are unmatched compared to other cervical interbodies on the market."
  • "NuVasive's expanded AMS portfolio for cervical applications provides surgeons with additional solutions to select the right material for their patient," said Matt Link, president of NuVasive.

Full Two-Year Data from Orthofix M6-C Artificial Cervical Disc Study Shows Significant Improvement in Pain, Function and Quality of Life Scores

Retrieved on: 
Thursday, April 4, 2019
Surgery, Health, Clinical trials, Medical devices, Medical Subject Headings, Medical classification, Medical specialties, Skeletal system, Neurosurgery, Intervertebral disc, Soft tissue, Cervical, Discectomy, ACDF, Neck, Vertebral column

View the full release here: https://www.businesswire.com/news/home/20190404005010/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20190404005010/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.
  • The data demonstrates that patients treated with the M6-C artificial cervical disc had significant improvements in neck and arm pain, function and quality of life scores.
  • The results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty versus discectomy with fusion, said Zigler.
  • This data statistically demonstrates that cervical disc replacement with the M6-C disc is not inferior to treatment with ACDF.