Is Cervical Disc Replacement Fda Approved

HEALTH EVIDENCE REVIEW COMMISSION (HERC)
Patients must meet FDA approved indications for use and not have any contra-indications. FDA approval is device specific but includes: Cervical artificial disc replacement offers a possible surgical alternative to spinal fusion ... Retrieve Here

Epidural Administration - Wikipedia, The Free Encyclopedia
(e.g. hip replacement), general surgery (e.g. laparotomy) and vascular surgery (e.g. open aortic aneurysm repair). As a sole technique for surgical the spinal cord terminates around the level of the disc between L1 and L2 Steroids may be injected at the cervical, thoracic, lumbar, ... Read Article

Cervical And Lumbar Disc Replacement—The Ease Of Revision
Cervical disc replacement can be readily originally an excellent candidate for an anterior Charité disc replacement and he fitted the FDA inclusion and exclusion criteria. Cervical and Lumbar Disc Replacement BUSINESS BRIEFING: ... Visit Document

The BRYAN® Cervical Disc System - YouTube
The BRYAN® Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy ... View Video

SURGERY WITH PRODISC-C ProDisc-C Total Disc Replacement Is ...
DENVER SURGEON PERFORMS FIRST CERVICAL DISC REPLACEMENT SURGERY WITH PRODISC-C ProDisc-C Total Disc Replacement is newest FDA-approved cervical disc. ... Return Document

ProDisc-C Total Disc Replacement Fact Sheet. - Synthes
The ProDisc-C Total Disc Replacement was approved by the FDA based on the results of this prospective, randomized, multi-center – The ProDisc-C Total Disc Replacement is implanted in the cervical spine through a of intractable symptomatic cervical disc disease (SCDD) by the FDA. ... Read Content

Disc Replacement Adjacent To Cervical Fusion
That is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are not commercially available in the United States. cervical disc replacement adjacent to an ACDF. 13 We hypoth- Disc Replacement Adjacent to Cervical Fusion: ... Read Here

Total Artificial Disc Replacement For The Spine
Total Artificial Disc Replacement for theSpine : Medical Policy Cervical artificial total disc replacement of FDA-approved prosthesis for degenerative outcomes of cervical disc replacement with the Prestige disc: ... View Doc

Factors Affecting Reoperations After Anterior cervical ...
Factors affecting reoperations after anterior cervical discectomy trials approved for cervical total disc replacement (TDR) (Prestige ACDF; Reoperation; Cervical disc replacement; IDE; FDA Introduction Since its introduction by Robinson and Smith in 1955, ... Read Here

Cervical Artificial Disc Replacement Clinical Coverage Criteria
Cervical Artificial Disc Replacement Clinical Coverage Criteria Page 1 of 1 Effective 05/01/2014 Cervical Artificial Disc Replacement Clinical Coverage Criteria ... Fetch Content

Active Duty Military DENIED Surgery - YouTube
Active duty military friend is denied back surgery by Tricare (Government). They claim that disc replacement surgery is an "Experimental procedure". FDA approved, but experimental. Welcome to SOCIALIST MEDICINE. Its on its way if the US Supreme court does not strike down "Obama Care ... View Video

CMS Manual System
CMS Manual System Department of Health & Human Services (DHHS) Medicaid Services (CMS) Transmittal 992 Date: JUNE 23, 2006 CHANGE REQUEST 5057 SUBJECT: Lumbar Artificial Disc Replacement (LADR) the only artificial disc approved by the FDA at this time, therefore the procedure (0091T or ... Access Content

Subject: Artificial Intervertebral Disc Replacement (AD R) S ...
Device is FDA approved for cervical disc replacement Following artificial cervical disc replacement, use of a cervical collar is not necessary. 37 GENERAL INFORMATION Summary of Medical Evidence Cervical: ... Access Full Source

Oregon Health Plan Prioritized List Changes Artificial Disc ...
Oregon Health Plan Prioritized List Changes Artificial Disc Replacement . Cervical artificial disc replacement . 1) Patients must meet FDA approved indications for use and not have any contraindications. ... Fetch Doc

CERVICAL ARTIFICAL DISC RECEIVES FDA APPROVAL
Natural spine disc movement with shock absorbing characteristics than a previously approved “Additional biomechanical studies indicate that disc replacement creates less adjacent level strain Bryan Cervical Disc receives preliminary FDA approval ... View Document

Medical Policy Manual Date Of Origin: Last Reviewed Date ...
Medical Policy Manual Topic: Artificial Intervertebral Disc Date of Origin: October 2003 Device name Manufacturer FDA Approved? I. Anterior total cervical disc replacement using an artificial intervertebral disc following complete ... Fetch Document

AxioMed Freedom Disc - Randall F Dryer, MD - YouTube
Dr. Randall Dryer has extensive experience with a variety if disc replacement devices and is currently enrolling patients in an FDA-approved clinical trial for the AxioMed Freedom Disc. 6818 Austin Center Blvd, Austin, Texas 78731. www.spine-ctsi.com ... View Video

Carotid Endarterectomy - Wikipedia, The Free Encyclopedia
Carotid endarterectomy (CEA) High cervical (C2) or intrathoracic lesion. The FDA has approved 7 carotid stent systems as safe and effective in patients at increased risk of complications for carotid surgery and 1 carotid stent system for patients at average or usual risk of carotid ... Read Article

ProDisc-C Total Disc Replacement Fact Sheet.
An IDE study was initiated in the summer of 2003. The ProDisc-C Total Disc Replacement was approved by the FDA based on the – The ProDisc-C Total Disc Replacement is implanted in the cervical spine through a The ProDisc-C Total Disc Replacement is indicated in skeletally ... Fetch Here

Artificial Cervical Disc Replacement Com
Artificial Cervical Disc Replacement FDA New Device Approval for BRYAN® Cervical Disc (May 12, 2009) FDA Summary of Safety and Effectiveness Data for ProDisc™-C Total Disc Replacement, December 17, 2007. Approved QIMT 6/19/08, 6/11/09, 7/8/10, 7/7/11, 7/5/12, ... Read Content

Lumbar Disc Replacement - Treatment For Low Back Pain
Lumbar disc replacement surgery is a treatment option for some types of low back pain. Recently FDA approved in the United States, When Is a Cervical Fusion Surgery Required? ... Read Article

Anterior cervical disc replacement Indications, Techniques ...
Anterior cervical disc replacement: Indications, techniques, and outcomes 7 cervical devices have been approved in the United States for disc arthroplasty. fairly consistent throughout the U.S. FDA approval process. At ... Access This Document

MEDICAL POLICY Artificial Intervertebral Disc Replacement
0375T), partial cervical disc replacement, planned procedure including the combined use of a cervical artificial intervertebral disc replacement and spinal Paramount considers an FDA-approved artificial intervertebral disc replacement medically necessary for ... Get Document

Cerivical Artificial Disc Replacement - FCHP
Cervical artificial disc replacement, also known as total disc arthroplasty, has been proposed as an alternative to anterio r cervical discectomy and fusion for the treatment Cervical Disc System (Medtronic) was FDA-approved in July 2007. ... Access Content

Total Disc Replacement Or Spinal Fusion? - About.com Health
The total disc replacement or a spinal fusion? About.com. Food; Health; Home; Money; Style; Tech; Travel; More Autos; Bendo JA, Kim Y, Spivak JM. The Incidence of Potential Candidates for Total Disc Replacement among Lumbar and Cervical Fusion Patient Populations. Asian Spine ... Read Article