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[NancyB]

I have a question. All Class III products have to be tested on human patients. It is the developer's onus to present CLEAR AND UNEQUIVOCOL clinical data on humans demonstrating the safety and effectiveness of his device. Why hasn't one single clinical trial been completed in Cyberonics seizure application? NCT00215215, NCT01118455 and NCT00522418 have all been terminated. NCT00625222 did not even begin untill 2/11/08, and that trial is not even being done on American soil. It is being done at the University of Luebeck. Do you mean to tell me that this device is being used all these years to treat seizures and it hasn't even met the requirements for clinical trial data mandated for all Class III medical devices, but has been allowed to seek another application? This device was approved to treat seizures in 1997, and these requirements should have been already met.

[Birdbomb]

MOST interesting find Nancy. I think I'll forward your post to a few people and see if we can get an answer!

[dennis100]

Hi Nancy, The clinical trials you referred to were post-market studies conducted by Cyberonics. They had nothing to do with the approval process. KEEP DIGGING !


ID # NCT00215215
 
Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
http://apps.who.int/trialsearch/trial.aspx?trialid=NCT00215215
 
 
ID # NCT01118455
 
Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-epileptic Drug Treatment in Children With Refractory Seizures
http://www.who.int/trialsearch/trial.aspx?trialid=NCT01118455



ID # NCT00522418
 
Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients
http://apps.who.int/trialsearch/trial.aspx?trialid=NCT00522418
 

ID # NCT00625222
 
Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
http://www.who.int/trialsearch/trial.aspx?trialid=NCT00625222

[Birdbomb]

Thanks Dennis. Keep up your diligence Nancy and Dennis.  It's go-getters like yourselves that get things accomplished.  We could use several more members like you guys!  Some of us old timers are just too tired, we've been through too much.