Status on artifical discs in the us

[Corry]

Up until November, I've been following the legal status of new discs in the us. That's November 2011. Let me apologize for the iPhone auto correct I'm typing with .

For those waiting for the maverick in the us. Stop. It's not going to happen. Synthes feels its too lucrative to have the us market cornered with their patent that isn't even valid. (written description is the ONLY thing that's supposed to count) and there hasnt even been a peep about any sort of licensing deal. Since there is a permenant injunction against the maverick, the FDA is NOT going to approve it. Why waste their time? (even though it would make our insurance appeals easier!). Medtronic also lost in the appeals at the us circuit court of appeals. They have not appealed any higher to the best of my knowledge!

I didn't follow the kineflex, but I suspect they were also sued by an emboldened Synthes.

I didn't like the flexicore either, so I didn't follow it. I couldn't find much positive about it when it came out though.

Spinal Kinetics, maker of the m6 has been sued by Synthes as well. Seems now they claim their patent covers any/all artifical discs. Truly an evil corporation IMO. Details of the suit were scarce, but it seems the courts will hear a spinal kinetics counter patent lawsuit in February of 2012. Here's hoping! I also don't know about clinical trials with the m6, but assuming they win the legal battle, realistically expect it to take 7 years to go through the FDA, from start if the trials, to the meeting which gains the approval. You can see their schedule online at FDA.gov, the cdrh is the group to watch for artifical discs.

Decide for yourself how long you can wait. I did for 10 years. My regret? Not going sooner, and not remaining active despite the pain, or at the very least, not having gone for pt just prior to surgery.

Simple google searches will pull up all the information here! Just search for synthes Medtronic lawsuit and Synthes Spinal Kinetics lawsuit, and spend some time on fda.gov

[Slackwater]

Originally Posted by Corry

Up until November, I've been following the legal status of new discs in the us. That's November 2011.DEL.TEXT
For those waiting for the maverick in the us. Stop. DEL.TEXT

I didn't follow the kineflex, but I suspect they were also sued by an emboldened Synthes.

Spinal Kinetics, maker of the m6 has been sued by Synthes as well. Seems now they claim their patent covers any/all artifical discs. Truly an evil corporation IMO. Details of the suit were scarce, but it seems the courts will hear a spinal kinetics counter patent lawsuit in February of 2012. Here's hoping! I also don't know about clinical trials with the m6, but assuming they win the legal battle, realistically expect it to take 7 years to go through the FDA, from start if the trials, to the meeting which gains the approval. You can see their schedule online at FDA.gov, the cdrh is the group to watch for artifical discs.

Decide for yourself how long you can wait. I did for 10 years. My regret? Not going sooner, and not remaining active despite the pain, or at the very least, not having gone for pt just prior to surgery.

Please see Spinal Kinetics v. Synthes Lawsuit, Dec 13, 2011.
Spinal Kinetics counter-sued Synthes and won in US District Court. This is a slight status change.

Agree with you that it might / will take time for other products to get FDA approval in the United States. I commented to Ronald Jean, CDRH, FDA, that patients have left the country for spine surgery out of frustration with the situation in the United States. I commented to Dr.Jean a couple of years in advance of Dr. Pettine writing the below. I hold no weight, just a patient making a comment.

ref:
Regulatory: ISASS Ann Mtg 2011 April 26-29

2011 Annual Meeting, April 26-29, International Society for the Advancement of Spine Surgery
Agenda and Abstracts Wed-Sat

General Poster #471
Metanalysis of how the Current FDA Has “Impacted Spine Innovation in the United States”
K.A. Pettine 1
1 The Spine Institute, Loveland, CO, United States

"Conclusion:
Many CEO's do not anticipate any new FDA IDE spine studies secondary to cost and FDA unpredictability of ever receiving approval.

Venture Capitalists cannot deal with this environment of unpredictability. The first question asked to any company is whether this is a 510(k) product, a 510(k) product requiring data or an IDE and what are the possibilities of the product ever being reimbursed. In the current environment, ideas are not getting funded. There is a major shift of investment capital and jobs to outside the U.S. The current FDA does not have our patients' best interest as a priority. "
~~~~~~~~~~~~~~~

Best wishes from this side,

slackwater_sf

[laid up doc]

Dr Pettine.... understatement of the year!!!

[Slackwater]

Originally Posted by laid up doc

Dr Pettine.... understatement of the year!!!

Agree with you. There may be more IDE's coming, but ... I looked at FDA 2011 goals / objectives. Part of the issue is changing their own internal processes. I think there are a lot of people there that want to do better.

Corry got it right, there are challenges.