FDA Approves Synthes Artificial Spine Disc -2-
Tuesday August 15th, 2006 / 22h35

The product from Synthes is expected to compete against Johnson & Johnson's (JNJ) Charite artificial disc, which was approved in 2004.
In its approval letter to Synthes, the FDA said patients receiving the disc should have tried at least six months of "conservative" treatment with other therapies.
As a condition of approval, the FDA said the company has agreed to continue studying the disc for long-term safety and effectiveness in a study that must involve at least 286 patients. The company will also be required to conduct a yearly analysis of major adverse events with the device along with the number of devices sold and implanted each year. All companies are required to routinely report problems with medical devices and drugs to the agency.

http://www.easybourse.com/Website/dynamic/News.php?News...g=fra&NewsRubrique=2

Good news!! Approval of the Pro logically leads us to hope and expect further approvals in the future, both in multilevels and other prostheses--ultimately meaning more equal competition and more choices for patients in the future.

One huge step forward, definitely worth celebrating! http://adrsupport.org/groupee_common...icon_smile.gif http://adrsupport.org/groupee_common...icon_smile.gif

Trace

I received this media release from Synthes. ProDisc will mean big bucks for Synthes

My doctor's office called me today and said that Synthes is not releasing the Prodisc until late September.

ADR Support Group: "BOO HISS! STRING 'EM UP!!!"

Eddie_G: "Hey I'm just the messenger....besides, hanging me will only make my back feel good"

ADR Support Group: "Grrrr....grumble grumble"

Eddie_G: "It gives us time to fight our insurance companies anyway"

ADR Support Group: "Yeah...LETS GET 'EM!!"

Eddie_G: "ONWARD TROOPS!!!"

ADR Support Group: "ONWARD TO OCTOBER!!!"



<span class="ev_code_WHITE">............................ .........................................</span>

I am also waiting to have surgery at at least two levels, so I'm disappointed in only single level approval. I've been keeping a blog for the last 6 months or so on my experiences with Degenerative Disc Disease. Have a look at
http://www.ingridsbackblog.blogspot.com/

It's all got to start somewhere even tho some us may be disappointed that the approval is for one level, this is good news for some people and is the beginning of use of FDA approved Prodisc here! We have to be glad for those that benefit by this!!!

The other thing is that insurance companies are probably still going to have the brakes on for a while so just hang in there as best you can~

Can anyone confirm if they are having Prodisc surgery before October?

I wonder if Synthes is really holding back on releasing the discs or if my surgeon just ran out of them.



Surgery anyone?



<span class="ev_code_WHITE">............................ .................................................. .............</span>

October-ish is when I will be calling Dr. Y's office to try and get a pre-auth from my insurance company (and of course, by 'pre-auth', I mean pre-denial)

I believe that the general idea was to give the insurance companies a couple of months to catch up with the approval (like they didn't already see it coming), probably from a perspsective of their coding systems.

David

There really should be one thread talking about approval. It's very confusing to new people who dont know how to search to have multiple threads on FDA approval of the Prodisc.

Just my .02

Is this the thread we should use?

I have an October 5, 2006 surgery (L5, ProDisc) scheduled with Delamarter. Just received denial from Blue Cross today. I do have another company available, Great-West--anybody know what their position is? I'd really like to proceed on Oct 5 rather than delay this.

Thank you in advance.
dan