ACDF

AlloSource Announces First Patients Implanted With AlloWrap Amniotic Membrane In Clinical Study For Two-Level Anterior Cervical Discectomy And Fusion Procedures

Tuesday, February 23, 2021 - 6:40pm

The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.

Key Points: 
  • The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.
  • "Though I have performed many successful anterior cervical discectomy and fusion procedures, I am always looking for ways to improve patient outcomes," said Dr. Paul Kim with The Spine Institute of San Diego.
  • AlloSource's AlloWrap is a human amniotic membrane designed to provide a biologic barrier following surgical repair in a multitude of procedures.
  • Founded in 1994, AlloSource is a nonprofit leader in providing allografts that maximize tissue donation to help surgeons heal their patients.

SeaSpine Announces Limited Commercial Launch of WaveForm™ TA (TLIF Articulating) 3D-Printed Interbody System

Monday, February 22, 2021 - 1:00pm

CARLSBAD, Calif., Feb. 22, 2021 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launch of its 3D-printed WaveForm TA (TLIF Articulating) Interbody Implant System.

Key Points: 
  • CARLSBAD, Calif., Feb. 22, 2021 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launch of its 3D-printed WaveForm TA (TLIF Articulating) Interbody Implant System.
  • WaveForm TA represents SeaSpines first 3D-printed lumbar interbody system and follows the September 2020 launch of its WaveForm C Interbody Implant System, designed to be used in ACDF (anterior cervical discectomy fusion) procedures.
  • I am a strong believer in 3D-printed interbody technology and SeaSpines WaveForm TA is the ideal implant for this area of my practice.
  • The 3D-printed interbody devices utilize the same instrumentation as the Reef TA Interbody System that SeaSpine launched in 2020.

Precision Spine® Receives FDA 510(K) Clearance for the Dakota ACDF™ Standalone System

Thursday, February 4, 2021 - 3:47pm

Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Dakota ACDF Standalone System in the treatment of degenerative disc disease (DDD).

Key Points: 
  • Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Dakota ACDF Standalone System in the treatment of degenerative disc disease (DDD).
  • The Dakota ACDF system features a titanium plate polyetheretherketone (PEEK) cage with cortical cancellous screws for maximum support and a generous cavity for autogenous bone graft to help facilitate fusion.
  • The Dakota ACDF System represents another example of how Precision Spine is making good on its commitment to develop surgeon-designed devices that embody the advanced features surgeons need to help improve OR efficiency and achieve positive patient outcomes, said Chris DeNicola, Chief Operating Officer of Precision Spine.
  • Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device such as the Dakota ACDF System.

SeaSpine Announces Full Commercial Launch of the Shoreline RT® Cervical Interbody Implant System

Thursday, August 27, 2020 - 9:05pm

CARLSBAD, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of the Shoreline RT Cervical Interbody Implant System.

Key Points: 
  • CARLSBAD, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of the Shoreline RT Cervical Interbody Implant System.
  • Shoreline RT describes a series of products that enhance NanoMetalene technology with the Companys proprietary Reef Topography.
  • Shoreline RT provides 40% more NanoMetalene endplate surface area and 50% more NanoMetalene aperture surface area versus Shoreline without Reef Topography.
  • The Shoreline RT system is designed to be used in ACDF (anterior cervical discectomy fusion) procedures as part of the Companys Shoreline ACS TruProfile Plating System or in combination with its Cabo anterior cervical plate.

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

Tuesday, June 30, 2020 - 12:20pm

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

Monday, June 15, 2020 - 11:00am

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

Tuesday, September 24, 2019 - 12:05pm

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

Thursday, September 5, 2019 - 1:33pm

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

Thursday, April 4, 2019 - 12:00pm
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.