Anterior cervical discectomy and fusion

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

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.

Cerapedics™ Announces Expansion of Headquarters to Support Growth of its Bone Graft Products

Retrieved on: 
Wednesday, July 19, 2023

"Since the launch of i-FACTOR, we have seen a continuous increase in its use in spinal fusion.

Key Points: 
  • "Since the launch of i-FACTOR, we have seen a continuous increase in its use in spinal fusion.
  • We are committed to supporting the needs of surgeons and their patients by expanding our facility," said Valeska Schroeder, Chief Executive Officer of Cerapedics.
  • i-FACTOR is the only spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide™, and it is just one of two FDA approved Class III drug-device bone grafts with a spinal indication.
  • This next generation product has been granted breakthrough status by FDA and is being studied under an investigational device exemption (IDE).

Providence Medical Technology announces FDA Clearance of the CAVUX® Facet Fixation System for the treatment of Cervical Pseudarthrosis

Retrieved on: 
Thursday, December 15, 2022

PLEASANTON, Calif., Dec. 15, 2022 /PRNewswire/ -- Providence Medical Technology, Inc., a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® Facet Fixation System (FFS) for a new indication. The Facet Fixation System (FFS) is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to provide stabilization until fusion occurs. 

Key Points: 
  • PLEASANTON, Calif., Dec. 15, 2022 /PRNewswire/ -- Providence Medical Technology, Inc., a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX Facet Fixation System (FFS) for a new indication.
  • The Facet Fixation System (FFS) is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to provide stabilization until fusion occurs.
  • Providence Medical Technology, Inc. is a privately held medical device company focused on innovative and tissue-sparing surgical solutions for cervical spine surgery.
  • The Providence family of products includes the CORUS Spinal System, CAVUX intervertebral implants, ALLY bone and facet screws, and ENTRUS Allograft Bone.

Endoscopic Spinal Surgery Market to Reach $1.09 Bn, Globally, by 2031 at 7.4% CAGR: AMR

Retrieved on: 
Thursday, November 24, 2022

PORTLAND, Ore., Nov. 24, 2022 /PRNewswire/ -- Allied Market Research recently published a report, titled, "Endoscopic Spinal Surgery Market by Product Type (Endoscopes, Endoscopic Devices), by Procedure type (Transforaminal Endoscopic Procedures, Interlaminar Endoscopic Procedures, Endoscopic Posterior Foraminotomy and Cervical Discectomy, Endoscopic Visualized Rhizotomy), by End User (Hospital and Clinics, Ambulatory Surgical Centers): Global Opportunity Analysis and Industry Forecast, 2021-2031". As per the report, the global endoscopic spinal surgery market size was accounted for $536.9 million in 2021, and is expected to reach $1.09 billion by 2031, growing at a CAGR of 7.4% from 2022 to 2031.

Key Points: 
  • As per the report, the global endoscopic spinal surgery market size was accounted for $536.9 million in 2021, and is expected to reach $1.09 billion by 2031, growing at a CAGR of 7.4% from 2022 to 2031.
  • Rise in adoption of minimally invasive surgeries across the globe and advantages such as faster recovery and greater patient compliance drive the growth of the global endoscopic spinal surgery market.
  • By product type, the endoscopic devices segment held the largest share in 2021, accounting for nearly three-fourths of the global endoscopic spinal surgery market, due to rise in demand for endoscopic spinal surgery around the globe.
  • However, the global endoscopic spinal surgery market across Asia-Pacific is projected to portray the highest CAGR of 9.4% during the forecast period, owing to investments by the public and private market players in this field.

Spine Wave Announces the Commercial Launch of the Defender® Anterior Cervical Plate and the Stronghold® C 3D Titanium Interbody Device

Retrieved on: 
Thursday, December 2, 2021

The Defender Anterior Cervical Plate is a titanium plate and screw system that provides fixation for anterior cervical fusion procedures.

Key Points: 
  • The Defender Anterior Cervical Plate is a titanium plate and screw system that provides fixation for anterior cervical fusion procedures.
  • The Defender Anterior Cervical Plate is a workhorse titanium anterior cervical fixation system for anterior cervical fusion.
  • Defender Anterior Cervical Plate together with Stronghold C 3D Titanium Interbody Device is a great alternative for my anterior cervical fusions, said Julio Petilon, M.D.
  • In addition to the Defender Anterior Cervical Plate and the Stronghold C 3D Titanium Interbody Device, Spine Wave offers a broad portfolio of advanced spine implant and biologic products.

Global Neurosurgery Devices Market (2021 to 2026) - Industry Trends, Share, Size, Growth, Opportunity and Forecasts - ResearchAndMarkets.com

Retrieved on: 
Wednesday, September 1, 2021

Some of the commonly used devices include neurostimulation devices, neurosurgical navigation devices and cerebrospinal fluid (CSF) management devices, such as curettes, dissectors, elevators and rongeurs.

Key Points: 
  • Some of the commonly used devices include neurostimulation devices, neurosurgical navigation devices and cerebrospinal fluid (CSF) management devices, such as curettes, dissectors, elevators and rongeurs.
  • Key Questions Answered in This Report:
    How has the global neurosurgery devices market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID 19 on the global neurosurgery devices market?
  • What is the structure of the global neurosurgery market and who are the key players?

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

(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

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.

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

Retrieved on: 
Friday, January 29, 2021

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.

NuVasive Expands Proprietary Porous PEEK Portfolio with Cohere XLIF Interbody

Retrieved on: 
Wednesday, November 18, 2020

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.