NeuroMonitoring

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Sunday, May 29, 2011

Medtronic Spine Products and Risks of Male Infertility?...?

I haven't read the "Spine Journal Original Article yet, so not sure what the details of the study that indicate risks of male fertility by Medtronic's inufse bone graft. But, the news certainly must open up further investigation and scrutiny, Patient safety should be given top priority.

Medtronic Infuse Bone Graft Lawsuits

Medtronic Infuse Lawsuit

Medtronic Infuse Bone Graft Lawsuit
The Infuse bone graft lawyers at Saiontz & Kirk, P.A. are investigating potential Medtronic lawsuits for individuals who have experienced problems after surgery on their cervical spine. 
Medtronic has been accused of actively promoting and marketing the Infuse bone stimulator off-label for use in the cervical spine, or neck.  They have also failed to adequately warn about the risk of life-threatening complications.
Potential Medtronic Infuse bone graft lawsuits are being evaluated throughout the United States for problems associated with use during neck surgery.  There are no fees or expenses unless a recovery is obtained.

BusinessWeek LogoStudy links Medtronic's Infuse to male infertility

A study published Wednesday links Medtronic Inc.'s Infuse spinal graft to a condition that can cause infertility in men.
The clinical study said men who were treated with Infuse were more likely to develop retrograde ejaculation than men treated with other bone grafts. Retrograde ejaculation is a condition in which semen goes into the bladder after ejaculation instead of leaving the body through the urethra. It's not harmful, but it can cause infertility.

MAY 26, 2011, 5:33 P.M. ET
Study Shows Male Infertility Risk With Medtronic Spine Product

The experiences of one surgeon are raising questions about the costs and risks of a Medtronic Inc. (MDT) bone-growth product, threatening to pressure further the company's spinal business.
According to a study made available Wednesday by The Spine Journal, men treated with Medtronic's Infuse product were more likely to develop a certain infertility problem than those who didn't get the product during spine surgery. Editorials in the medical journal questioned why the issue wasn't examined more in Medtronic-funded studies and noted Infuse's high price tag.
The study, though, has limitations because it's based on procedures done at one hospital by ... 

New Study Links Spine Product From Medtronic to Risk of Sterility in Men

By and
Published: May 25, 2011
A surgeon at Stanford University, in a study released Wednesday, suggests that one of Medtronic’s best-selling spinal products poses a risk of male sterility. That finding is in stark contrast to earlier research by doctors paid by Medtronic, who found no connection between the product, Infuse, and a condition that causes sterility. 

Medtronic site published this description of the product?
BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR:
INFUSE® BONE GRAFT/LT-CAGE® LUMBAR TAPERED FUSION DEVICE
INFUSE® BONE GRAFT/INTER FIX™ THREADED FUSION DEVICE
INFUSE® BONE GRAFT/INTER FIX™ RP THREADED FUSION DEVICE
The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. The INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device is to be implanted via an anterior open or an anterior laparoscopic approach. INFUSE® Bone Graft with either the INTER FIX™ or INTER FIX™ RP Threaded Fusion Device is to be implanted via an anterior open approach.To Read further:
https://www.infusebonegraft.com/infuse_indications.html
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NeuroMonitoring Companies: Europe

Providers in Europe:
Intraoperative Neuromonitoring Practice at UniversitatsSpital Zurich:

NeuroMonitoring Suppliers in Europe:
1.CPS Medical: NeuroCode AG

NeuroMonitoring Supplier in Russia:
1.Neurosoft, Medical Diagnostic Equipment
Worldwide Distribution list

IONM in New Zealand:

What are the chances of getting a job?

Opportunities to get into neurophysiology technologist jobs are very limited, as there are only 20 neurophysiology technologists employed in New Zealand.

IONM in Switzerland:
Anandic Medical Systems a local Swiz company with GE Partnership that does neuromonitoring and neonatal pediatric neuromonitoring monitoring.

Medical/Health Care: Insurance Companies and IONM Policies, in their Eyes!?

Here is what the insurance Co Anthem Blue thinks about what is medically necessary or investigational as per their policies!

BlueCross BlueShield of Tennessee Medical Policy Manual

  • Intraoperative neurophysiologic monitoring, including, but not limited to the following: Somatosensory-evoked potentials, brainstem auditory-evoked potentials, visual-evoked potential, EMG, motor-evoked potentials, and EEG, when performed during spinal, intracranial, or vascular procedures, is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

  • Intraoperative neurophysiologic monitoring for other indications is considered investigational.

  • Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational. See also: Visual and Auditory Evoked Potential

Beware:- Do We Need this column?

Moved from Main page:-
Do Not Become victim to some New Org, association or society...! WARNING:- Be careful in signing up to some rogue organizations and memberships, You must realize that even professionals become prey for such tactics of bottom feeders, just think before you pay that fee, do we need another neuromontioring group, or organization or association bullshit?. They do not deserve to be even in the radar of scientific and medical communities, sorry!!!. I can only alert you, the rest is in your own hands, just because some one claims to have done or do the same kind of job a Professional and trained scholar can do, it means a jack shit!!!?, A doctor and a Doctarate cannot be replaced, those who claims to be doing some jobs can do something, but be careful to assess or compare it to a Doctor or Doctorate, such comparison will fail!!!. Society for Neuroscience and American Association of Anatomists are some of the most respectable and reputed scientific organizations, I dropped off my membership mainly because of their increased fees, I thought it was unjustified and unreasonable, but my respect to those two organizations will never be altered, they deserve great respect for what they do. Tthis message is not about such great associations, on the other hand it is about some rogue individuals trying to con the school students in IONM field or undergraduates who call themselves to be a neurophysioliogist??.Do not think that all the scientific or clinical organizations out there deserve the same respect like that of society for neuroscience or American association anatomists or American clinical Neurophysiologists or least they do the right things!!. Oh wait that is for those established organizations are out there already not for some rogues, but I have been seeing some internet activities of some rogue and decorated Neuromonitoring associations and societies trying to sprung up, just be careful about such org.The above message I had put up on my LinkedIN is to alert you, there are only a couple of Neuromonitoring associations established and in business already and they are good enough, we do not need every tom, dick and harry who did not even go to graduate school to start a association in the name of he or she is a tech for 10000 surgical cases, a Doctor and Doctorate cannot be replaced and there is no exception to it, so beware about rogue people starting societies and organizations and do not waste your hard earned money and resources to it...... stick to the deserved.