Discectomy

Spinal Elements® Announces Full Commercial Launch of Luna® XD and Orbit™ Systems

Retrieved on: 
Wednesday, September 15, 2021
Biotechnology, Surgery, Medical Devices, Hospitals, Health, CEO, MIS, Patient, North American Spine Society, Lordosis, Solution, Luna, Element, Multimedia, Radicular pain, Discectomy, Beth Israel Deaconess Medical Center, Medical device

Spinal Elements, a spine technology company, today announced the full commercial launch of the LunaXD multi-expandable lumbar interbody fusion device and Orbit articulating discectomy systems.

Key Points: 
  • Spinal Elements, a spine technology company, today announced the full commercial launch of the LunaXD multi-expandable lumbar interbody fusion device and Orbit articulating discectomy systems.
  • Luna XD and Orbit have been integrated into Spinal Elements as the newest technologies in its MIS Ultra platform of products and procedural solutions.
  • View the full release here: https://www.businesswire.com/news/home/20210915005364/en/
    Spinal Elements Announces Full Commercial Launch of Luna XD and Orbit Systems (Graphic: Business Wire)
    The Orbit system consists of articulating and rotating discectomy instrumentation that uses a minimal, posterior incision and/or MIS tubular approach to achieve efficient disruption and removal of disc tissue while preparing the endplates for fusion.
  • Spinal Elements will feature the Luna XD and Orbit systems at the upcoming meeting of the North American Spine Society in Boston on September 29through October 2, 2021.

Orthofix Announces FDA Clearance and Initial Patient Implant of the Company’s First 3D-Printed Titanium Cervical Spacer System with Nanovate Technology

Retrieved on: 
Monday, April 5, 2021
FDA, Health, Medical devices, Medical specialties, Surgery, Clinical medicine, Anterior cervical discectomy and fusion, Spacer, Construx, Titanium, ACDF, PTC, Discectomy

(NASDAQ:OFIX), a global medical device company with a spine and extremities focus, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and the first patient implant of the 3D-printed CONSTRUX Mini Ti Spacer System .

Key Points: 
  • (NASDAQ:OFIX), a global medical device company with a spine and extremities focus, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and the first patient implant of the 3D-printed CONSTRUX Mini Ti Spacer System .
  • Developed to enhance anterior cervical discectomy and fusion (ACDF) procedures, the CONSTRUX Mini Ti cervical spacer with Nanovate Technology is the first 3D-printed titanium interbody introduced to the market by Orthofix.
  • View the full release here: https://www.businesswire.com/news/home/20210405005029/en/
    Image of Orthofixs first 3D-printed titanium interbody, the CONSTRUX Mini Ti Cervical Spacer System with Nanovate Technology.
  • The CONSTRUX Mini Ti Spacer System with Nanovate Technology is one of many Orthofix products with nanotechnology FDA clearance including the CONSTRUX Mini PTC Spacer System, the Pillar SA PTC Spacer System, and the FORZA PTC Spacer System.

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

Retrieved on: 
Tuesday, February 23, 2021
Medical specialties, Clinical medicine, Surgery, Neurosurgical procedures, Anterior cervical discectomy and fusion, Neurosurgery, ACDF, Discectomy, Allotransplantation

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

Retrieved on: 
Monday, February 22, 2021
Anatomy, Branches of biology, Alif, Discectomy, ACDF, Vertebral column, Waveform

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.

Synergy Disc® Announces Enrollment of First Patient in US IDE Clinical Trial

Retrieved on: 
Friday, January 29, 2021
Surgery, Health, Medical devices, Medical specialties, Surgery, Clinical medicine, Neurosurgery, Neurosurgical procedures, Degenerative disc disease, Discectomy, Anterior cervical discectomy and fusion

Synergy Disc Replacement Ltd., a Colorado-based spinal medical device company and wholly owned subsidiary of Synergy Disc Replacement Inc. (SDRi), announced today that it has enrolled the first patient in its U.S. IDE clinical trial.

Key Points: 
  • Synergy Disc Replacement Ltd., a Colorado-based spinal medical device company and wholly owned subsidiary of Synergy Disc Replacement Inc. (SDRi), announced today that it has enrolled the first patient in its U.S. IDE clinical trial.
  • The Synergy Disc trial is a multi-center, prospective, historically controlled study that will be conducted on 175 patients at up to 15 sites in the U.S.
  • This trial is designed to demonstrate that the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion in patients with one-level symptomatic cervical degenerative disc disease (DDD).
  • at Austin Neurosurgeons in Austin, Texas has performed the first surgery utilizing the Synergy Disc in the United States.

Spinal Elements® Announces the Acquisition of Benvenue Medical Assets

Retrieved on: 
Wednesday, December 16, 2020
Medical devices, Health, Hospitals, Surgery, General Health, Biotechnology, Medical specialties, Surgery, Anatomy, Neurosurgery, Discectomy, Spinal fusion, Vertebral column, Spine

Spinal Elements, a spine technology company, today announced the acquisition of the assets of Benvenue Medical, Inc., a developer of MIS lumbar fusion systems.

Key Points: 
  • Spinal Elements, a spine technology company, today announced the acquisition of the assets of Benvenue Medical, Inc., a developer of MIS lumbar fusion systems.
  • View the full release here: https://www.businesswire.com/news/home/20201216005329/en/
    Spinal Elements Announces the Acquisition of Benvenue Medical Assets (Photo: Business Wire)
    Benvenue had recently introduced the next generation Luna XD system based upon years of experience with a prior generation device.
  • The acquisition of these Benvenue assets marks another transformational MIS investment for Spinal Elements, said Jason Blain, President and CEO of Spinal Elements.
  • In addition to the Luna XD implant system and Orbit discectomy system, Spinal Elements acquired Benvenue Medicals manufacturing production equipment.

NuVasive Expands Proprietary Porous PEEK Portfolio with Cohere XLIF Interbody

Retrieved on: 
Wednesday, November 18, 2020
Medical specialties, Surgery, Clinical medicine, Neurosurgical procedures, Anterior cervical discectomy and fusion, NuVasive, Spinal fusion, Polyether ether ketone, Peek, Discectomy

Cohere XLIF is a key addition to NuVasive's Advanced Materials Science (AMS) implant portfolio, consisting of proprietary surface and structural technologies, and is designed for bone in-growth while maintaining the imaging and mechanical properties favored in smooth PEEK and titanium coated PEEK interbody devices.

Key Points: 
  • Cohere XLIF is a key addition to NuVasive's Advanced Materials Science (AMS) implant portfolio, consisting of proprietary surface and structural technologies, and is designed for bone in-growth while maintaining the imaging and mechanical properties favored in smooth PEEK and titanium coated PEEK interbody devices.
  • "Combined with Cohere XLIF, the Cohere XLIF AMS plate equips surgeons with additional technology when pathologic features call for it and gives confidence in a patient's path to returning to normal activities."
  • The Porous PEEK technology in Cohere XLIF has been recently studied head to head in cervical spine fusion against smooth PEEK and structural allograft bone.
  • Early clinical outcomes comparing porous PEEK, smooth PEEK, and structural allograft interbody devices for anterior cervical discectomy and fusion.

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

Retrieved on: 
Thursday, August 27, 2020
ACDF, Discectomy

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

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.

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.