Future of Nuva

Any predictions on what's in store for the next couple years at Nuva?

 

1 in 40 who got XLIF died:

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

6 out of 20 who got PLIF died, 3 within 3 months post surgery.

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1918239

Surgeon reported to the FDA Maude that the Neurovision JJB System didn't work properly.

Nuvasive replied :

"the neurovision jjb system may not be effective, and is not intended for use, when muscle relaxants or epidural blocks have been used for, or in conjunction with, anesthesia. "


Wait a minute...aren't all XLIF's done under anesthesia? ha ha ha ha ha ha ha!!!!!!

 

http://www.bloomberg.com/news/2010-...-with-fusion-surgery-debunked-by-studies.html

I wonder why Bloomburg stabbed JP Morgan in the back like that? Why would Bloomburg want to fiddle with JP Morgan's currect cash cow???

 

Holy crap that Maude Report above, it took the surgeon 2 years to report it to the FDA/manufacturer/

21 US Code 803.30.....says he was supposed to report it within 10 days.

Why did he even bother reporting it so long after the procedure? It's not like anybody knew about the event 2 years down the road. His conscience was bothering him??

 

oh I see on 21 US Code 803.40 the surgeon had up to 30 days to report to MAUDE something bad happened....not 10 days.

Still why did he bother reporting it so long after it happened? Nobody remembers anything they did 2 years ago....something don't seem right.

 

Umm... No stimulated EMG will work with paralytics. Should have talked to anesthesia...

 

The Federal Govt. has started cracking down on "off label use" of drugs and medical devices.

The Fed's need revenue. It's a tool they use at times.

I see a medical device maker being charged by the US Justice Department for pushing it's product to be used without fixation during marketing...when their 501k letter signed by the FDA says Fixation must be used.

False advertising. Their 501K letters shouldn't have had the sentence "fixation required".

Then again maybe the whole scandal was fabricated in the first place to make lots of money....even if it killed/crippled people. People are sacrificable. If money can be made.

How does everyone else view the above and do they think it will unfold?

 

Hey 12:22 -- What is a 501k? You mentioned it twice. Do you mean 510k?

 

correct, 510(k) K043405

Does anyone know how many people were given that Class II Medical Device without fixation?

Rough guesstimate, hundreds? thousands?

 

Is the XLIF procedure still being done with the Coroent PEEK spacer without using Fixation?

 

This was known for awhile:

www.ncbi.nlm.nih.gov/pubmed/20965732

""An unrecognized complication after XLIF""

Patients were complaining heavily back as far as '08 and doctors were noting femoral nerve damage in knee reflex tests shortly after surgery.

Is the term "Minimally Invasive" dead yet?

 

http://thejns.org/doi/abs/10.3171/2011.2.SPINE10369?journalCode=spi

Acute Renal Failure from XLIF....maybe from too much fluoroscopy? 4 hours to do a 1 level fusion is a lot of radiation.

 

Looks like Nuvasive's lawsuit is going to be expensive:

http://www.massdevice.com/news/judge-nixes-medtronic-nuvasive-motions-patent-infringement-case

They claimed 12 patent infringements by Nuvasive.

 

What exactly is going on with Nuva. Can someone give me the cut and dry. I know they pretty much pioneered the XLIF procedure and seems to be catching on. Are there really reimbursement issues with the XLIF and how are surgeons responding to it? I watched an XLIF procedure done on youtube the other day, and it seemed pretty simple, about an hour for the procedure with minimal blood less and tissue damage..which is apparently NuVasive's claim to fame here. I understand that XLIF is Nuva's one-trick pony...but is it not doing well? Is the pony successful as compared to MDT's and the Stryker's and the Synthes' out there? I don't see why surgeon's wouldnt prefer doing this surgery as opposed to 2-3 hr ALIF or PLIF. It's cheaper and easier on the patient.

Any thoughts?

 

"""It's cheaper and easier on the patient.""

It's not cheaper, insurance companies are being billed for a full fusion now.

XLIF= eXtreme Lateral Interbody Fusion.....problem is there's no fusion being done.

Maybe why Nuvasive claims a Common Law copyright on the letters "XLIF" and doesn't apply to get it copyrighted? It's name alone would be medical fraud. There's no fusion being done.

It's cheaper for doctors to do and make fast money. It's not easier on the patients. They are getting 4 hours of fluoroscopy for a 1 level fusion, not the 1 hour as advertised. Plus their vertebrae aren't being bolted together...infections...bone not fusing...disc implant migration. Doctors have not been reporting XLIF complications because the money's too good.

 

Whomever this guy is that keeps posting about nuva and xlif is a complete moron. Fusion rates and long term data is out and peer reviewed. Average or time is out in multiple studies, and are around an hour maybe 2 per level. And there are plenty of fixation options besides stand-alone cages. Lateral plates, facet screws, spinous process plate, perc screws on and on.

Honestly, who are you? As you dont know shit

 

http://w3.cns.org/dp/2011DSPN/252.pdf

Higher rate of failure when Coroent disc spacer is used without fixation.

www.XLIFclassaction.com

 

""Average or time is out in multiple studies, and are around an hour maybe 2 per level.""

The World Spinal Column Journal, Volume 2, 2011 issue.

Average time of 3.68 hours for a 1 level XLIF.

95% of the people they operated on they used Fixation. Looks like less and less surgeons are using the Coroent plastic disc spacer without Fixation.

Why is that?

 

Not looking good for Nuva

 

""there are no formal professional society statements supporting lateral interbody fusion in the form of XLIF or DLIF""

http://www.cigna.com/customer_care/...ria_lumbar_fusion_degenerative_conditions.pdf