Medtronic Spine vs Nuvasive

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Is it true Nuvasive was advertising their procedure as a simple disc yank and hammer in the plastic spacer...close the patient up and collect the full rate for a spine fusion?

When in fact they were never fixating peoples spines per the FDA approval letter for the implants?

Did the FDA issue guidance on May 3rd 2004 with the Spinal System 501(k's) Guidance for Industry and Staff notice saying there was significant risk and there were supposed to be Institutional Review Board and Informed Consent for these plastic spacers that somebody wanted to jam in peoples spines?

Were people actually informed they were receiving plastic spacer implants that in no way shape or form was actually going to hold the vertebrae together so the bone could grow together?

Is it true they KNOW people are not fusing and that's why the FDA came out with the "Bayesian" Statistics new theory saying instead of facts they will "learn from evidence as it accumulates". Are they really so evil that to get the economy going they would purposely allow people to be severely disabled so some IPO can run money from stock/JP Morgan into peoples hands to keep patients rolling in for $$$$$$ Bankrupting people trying to come up with funds to pay for the damage from their plastic implant moving around in their body and their vertebrae not fusing?

Could our government really be that evil? You betcha. Ain't no "One Trick Pony". This Pony's got connections in high places. Funneling those stock profits into politicians pockets seams to lube the wheels that allow it all to go around.
 






Anonymous said:
Is it true Nuvasive was advertising their procedure as a simple disc yank and hammer in the plastic spacer...close the patient up and collect the full rate for a spine fusion?

When in fact they were never fixating peoples spines per the FDA approval letter for the implants?

Did the FDA issue guidance on May 3rd 2004 with the Spinal System 501(k's) Guidance for Industry and Staff notice saying there was significant risk and there were supposed to be Institutional Review Board and Informed Consent for these plastic spacers that somebody wanted to jam in peoples spines?

Were people actually informed they were receiving plastic spacer implants that in no way shape or form was actually going to hold the vertebrae together so the bone could grow together?

Is it true they KNOW people are not fusing and that's why the FDA came out with the "Bayesian" Statistics new theory saying instead of facts they will "learn from evidence as it accumulates". Are they really so evil that to get the economy going they would purposely allow people to be severely disabled so some IPO can run money from stock/JP Morgan into peoples hands to keep patients rolling in for $$$$$$ Bankrupting people trying to come up with funds to pay for the damage from their plastic implant moving around in their body and their vertebrae not fusing?

Could our government really be that evil? You betcha. Ain't no "One Trick Pony". This Pony's got connections in high places. Funneling those stock profits into politicians pockets seams to lube the wheels that allow it all to go around.
Click to expand...

I would love to hear your theory on who shot JFK. Please share.
 






Can someone post a link to the FDA approval letter for the nuvasive plastic cage implant that surgeons have been inserting into people WITHOUT fixation?

Where is it?

Why are they getting paid for a full fusion when this procedure never fuses two vertebrae in any way, shape, or form? Why did the FDA allow this all to happen? Who's getting bought off in the FDA? Anybody got a name?
 






Anonymous said:
Can someone post a link to the FDA approval letter for the nuvasive plastic cage implant that surgeons have been inserting into people WITHOUT fixation?

Where is it?

Why are they getting paid for a full fusion when this procedure never fuses two vertebrae in any way, shape, or form? Why did the FDA allow this all to happen? Who's getting bought off in the FDA? Anybody got a name?
Click to expand...

I can completely appreciate your issue with NuVasive. I don't really like them either.
But, they just sell implants. The surgeon is the one using it off label. They, or any other implant manufacturer, etc, doesn't dictate what the patient uses or how he uses it. If you really looked into what's being done in surgery, many implants are used "Off Label."

The product is approved for use in conjunction to a fixation device. If the surgeon chooses to not use those other devices, he takes that burden on.
 






""If the surgeon chooses to not use those other devices, he takes that burden on.""

No he doesn't. With NASS's recent approval to bill insurance as a full fusion...when no fusion was done.....

Industry and the FDA have blessed the procedure as a "fusion"...without fixation.

Hmmm people dying from not being fused?

www.seriousinjurylaw.co.uk/news/Spi...-not-be-denied-minimally-invasive-surgery.php

High death rates for such a small pool of people isn't it?

It's got the Federal blessing because they need lots of money exchanging hands right now for the economy. If a small group gets disabled/ or dies.....they are expendable.

Aren't they America???
 






""""The surgeon is the one using it off label. They, or any other implant manufacturer, etc, doesn't dictate what the patient uses or how he uses it.""""

Those spine spacers are Class II medical devices. By Prescription only, doc signs for em right?
21 US CODE ,820.170

A- manufacturer gives instructions for device

B- installer must follow instructions.


doc's liable for not using fixation. Doc gets sued.
Doc could turn around and sue Nuvasive for advertising device didn't need fixation in videos. Company Reps never told any surgeons they should have used fixation while watching procedures.

Is that how it would unfold?
 






This forum goes back a few years, but all I can say is that I am shocked by the utter immaturity and seemingly disrespect for the human beings we call patients. Don't know who those two clowns in the earlier discussion work for, but hopefully they have found their calling elsewhere.

A couple of moot points... a solid fusion does not equate into good outcomes! From the limited interactions the reps have with patients and the 'beautiful' intraoperative/postoperative radiographs, one cannot tell me how superior his/her products are. There is certainly some truth to the word marketing and a physician using using what they are comfortable with when it comes to implants/instrumentation.

From a personal note, I guess I am a bad/terrible surgeon because I do not use any lateral approaches because I had a bad outcome. I can accomplish the same operation posteriorly and after 10 years, I have not had the same bad outcome as I did with the lateral approach.

One can follow all the recommendations given for an implant, but it does not translate into favorable outcomes. These implants do fail! They break, migrate and FAIL! Poor technique or BAD surgeons are not the only reasons.

It is almost comical as well re. the surgeon using these implants off-label... I wonder if the reps reiterate this point when the doc is attempting to implant the instrumentation in the OR!
 






Help! Medtronic Spine vs Nuvasive

I need some advice. I just left the Army after 9 years and have no med device experience. However, I was just offered a slot at Medtronic for their SER (Sales education rep) in the Interventional (Kyphon) side. 12 months in school, mostly Memphis then apply for territory rep.

also, NuVasive wants me to be an associate rep in SoCal. I live in Socal as does my girlfriend.

What are the pros and cons?

They want an answer in 48 hrs...........

What should I do?

thanks.
 






Bringing this thread back from the dead! It's 2017 and NuVasive has a lock on #3 (and growing) in the Global & Domestic Spine Market. Sure, XLIF put NUVA on the map but they have some other innovative technologies with Bendini, MAGEC, LessRay and a pretty solid overall bag with iGA as a focus on alignment and a very good Posterior deformity and MIS system, RELINE. From a business perspective, new CEO Lucier has made his mark and transformed a company who once burned thru cash to one that's turning a profit. They open the doors on their own manufacturing plant in 2017, so expect more efficiency and profitability. That said, rumors are that the culture has shifted, the visionary founders have all come and gone (Lukianov, Valentine, and recently Miles taking a back seat) and the infrastructure is sagging and struggling to support the growth.

Medtronic, tired of losing market share, re-organized the Restorative Therapies Group and have new leadership from the Neuro side that are used to winning and are flexing their big blue muscles. As a result, Nav and Spine are working together and Spine has started to grow again. RTG is just about to wrap on another great year. OArm2/Stealth2 has pulled through a ton of business, Elevate expandable cage is a success, OLIF is starting to grow with the hiring of former NuVasive reps/XLIF gurus as "OLIF Regional Managers," and the MAZOR Robot is coming soon to an OR near you.

It will be interesting to watch these two great companies battle it out. DePuy Synthes is an afterthought. They aren't innovating. They will be passed by NUVA by 2019.

Source: I have worked for both NUVA and MDT.
 












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