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The Big File All issues not easily categorized in the above forums are here. Comments on general health, diet, "getting comfortable," and more are here. |
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#31
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Injured 9/01 Annular tears L4/5 & L5/S1 denied adr by insurance for 2 level charite as well as hybrid fusion at L5/S1 with Charite at L4/5. New ins paid for 2 level lumbar prodisc surgery on 4/7/08 (at age 39) with Dr. Westerlund, at Core Orthop |
#32
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I seriously hope it is for two level approval, but my guess would be for one level, with two level coming later David
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47 years old Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.) L4-S1: Prodisc |
#33
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[/QUOTE]
That would be some excellent news! I wonder if that might be the reason Dr. Y's webpage has significantly changed since I last visited? (I just happened to visit it yesterday) I seriously hope it is for two level approval, but my guess would be for one level, with two level coming later David[/QUOTE] Can you please give me Dr. Y's homepage address? What happened? |
#34
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Injured 9/01 Annular tears L4/5 & L5/S1 denied adr by insurance for 2 level charite as well as hybrid fusion at L5/S1 with Charite at L4/5. New ins paid for 2 level lumbar prodisc surgery on 4/7/08 (at age 39) with Dr. Westerlund, at Core Orthop |
#35
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From an Activ-L prospective, the start date changes. I believe it has changed from: --2006 --March 2006 --Late 2006 --Late Summer 2006 David
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47 years old Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.) L4-S1: Prodisc |
#36
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I know this is an old article but I bolded the part I found interesting...I still don't understand why the FDA hasn't yet approved the single level arm of the study. Could Synthes actually asked them to hold off with final approval , until the 2 level arm was approved as well?
see http://www.orthosupersite.com/defaul...=view&rid=5142 I've cut and pasted it below: New artificial disc awaiting final FDA approval Once approved, the ProDisc-L will be available in the United States for treating lumbar spine DDD at a single level from L3-S1. 1st on the web (January 9, 2006) January 2006 Synthes Inc. has received a letter from the FDA notifying the company that its premarket approval application for the ProDisc-L total disc replacement is approvable pending an inspection of related manufacturing facilities, the company announced. If approved, this will be only the second artificial disc to receive marketing clearance in the United States as an alternative to fusion for single-level degenerative disc disease (DDD). The ProDisc-L is awaiting final FDA approval as an alternative treatment for lumbar spine DDD at a single level from L3-S1. COURTESY: SYNTHES INC. The FDA based its decision on the results of a clinical trial conducted over four years with 292 patients at 17 sites. The study compared the efficacy of ProDisc-L to circumferential fusion on outcomes such as pain and disability, neurologic status, and maintenance or improvement of flexion-extension/range of motion at the index level. Patients were followed for two years postop, according to a press release. The FDA will issue its approval order for the company’s PMA after it completes and reviews an inspection of Synthes’ Brandywine, Pa., manufacturing facility. Peter Fehlmann, an official in the investor relations department at Synthes, told Orthopedics Today that the FDA has not yet scheduled an inspection date. “We are waiting for it, and it is basically a date that the FDA will decide upon,” he said. Despite the “approvable” letter from the FDA, Fehlmann noted that the company cannot release study data until it receives the final approval order. With final approval the ProDisc-L will be available in the United States as an alternative treatment for lumbar spine DDD at a single level from L3-S1. The company is also considering seeking approval for additional indications. “We did conduct a second arm to the study, which is for multi-level procedures or two-level procedures. But we will first wait for the approval order for the single-level device and then also take into consideration the overall market environment before we decide on how we want to progress with the PMA for the multi-level procedure,” Fehlmann said. The ProDisc-L is currently available in most European countries as well as some countries in Asia.
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Injured 9/01 Annular tears L4/5 & L5/S1 denied adr by insurance for 2 level charite as well as hybrid fusion at L5/S1 with Charite at L4/5. New ins paid for 2 level lumbar prodisc surgery on 4/7/08 (at age 39) with Dr. Westerlund, at Core Orthop |
#37
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I would pay some good $ to find out what the FDA and Synthes are up to....
David
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47 years old Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.) L4-S1: Prodisc |
#38
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What? You thought these people actually CARED about you? BWWAAHAHAHAHAHAHAHAHA HEY FDA: JUST APPROVE THE D*MN DISC SO I CAN GET MY LIFE BACK!!! YOU APPROVED BOTOX AND BIG BOOBS! HOW ABOUT A HUNK OF METAL FOR MY BACK!!! SOMEBODY BRIBE HILLARY CLINTON!!! WHATEVER IT TAKES!!! DO SOMETHING PAUL PROCRASTINATOR!!!
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12/16/03 Work Accident Herniation and DDD at L4-L5 4/1/05 Discectomy Epidurals and facet injections 5/15/06 Discogram confirmed L4-L5 DDD also an asymptomatic L5-S1 tear 10/24/06 L4-L5 Prodisc surgery with Dr. Goldstein CAT scans & X-Rays show ossification Trigger Point Injections, Medial Branch Blocks, Acupuncture, Weekly Deep Tissue Massage 10/27/08 Discogram (positive L5-S1 tear) 11/25/08 L5-S1 fusion with Dr. Goldstein FAILED BACK SYNDROME Liberty Mutual WC |
#39
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Thursday is over and no phone call from Dr. Kropf's office. Do you think they will call me tomorrow?
I doubt it very much. Are we all pissed off or what? This is such b.s. and you are right Eddie they approve so much stuff that is really not necessary, and us injured people who are in need, are having to put our lives on hold for a decision that cant yet be made. What is the hold up???
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Dina Injured 8-24-2000 DDD L5-S1 DDD C-4,5-5,6 Epidural steroid injections lumbar & cervical x-rays, mri's, etc. waiting for Prodisc for L5-S1, and Prodisc C for two levels on C-4,5-5,6 |
#40
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Upon the advice of my attorney, I decline to answer that question on the grounds that I will probably curse a lot....
David
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47 years old Surgery: 14-NOV-2006; Straubing, Germany (Dr. B.) L4-S1: Prodisc |
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