Information, Data, Documents and Publications supporting FDA Approval and favorable insurance coverage for VNS Therapy

TRD Regulatory Documents and Clinical Data
Current Labeling
Bibliography
Payor Communications
Links to the FDA Website

All documents are in Adobe Acrobat format. Click here to get Acrobat.

TRD Regulatory Documents and Clinical Data

1. TRD Revised Statistical Analysis Plan 10/03/2002 (19.6 MB)
2. TRD PMA Supplement Submitted to FDA on 10/24/2003
• October 24 2003 Cover Letter (25.2 MB)
• D-01 Study Report (4.4 MB)
• D-02 Study Report (25.7 MB)
• D-02 and D-04 Clinical Report (8.1 MB)
3. Final Pre-Panel Meeting Clinical Executive Summary Submitted to FDA on 4/17/2004
• Clinical Executive Summary (0.2 MB)
4. Cyberonics' written comments on draft FDA Clinical and Statistical Reviews and Advisory Panel slides provided to FDA prior to the June 15, 2004 FDA Advisory Panel meeting
• Cyberonics' letter to FDA dated 5/27/2004 regarding the draft FDA Clinical and Statistical reviews
• Cyberonics comments on draft FDA Panel slides provided to FDA on 6/13/2005
5. TRD PMA Supplement Amendment Submitted to FDA on 9/23/2004
• Cover Letter (0.1 MB)
• Response & Rebuttal to Not Approvable Letter dated 8/11/2004 (2 MB)
• Clinical Report Including New, Two-Year Longitudinal Data and Analyses and New, One and Two Year Sustained Response Data and Analyses (1.9 MB)
6. FDA Summary of Safety & Effectiveness dated 7/21/2005 that states:
   "In conclusion, CDRH believes that the PMA applicant has provided reasonable assurance of safety and effectiveness based on valid scientific evidence as required by statute and regulation for the approval of a Class III medical device.  CDRH has come to this conclusion because the sponsor has provided data that were systematically collected and analyzed which showed significant improvement from baseline over one and two years for a definable subset of the target population, and comparative data against a reasonably matched control which also showed sustained improvement over time."
• Summary of Safety and Effectiveness (1 MB)
7. FDA's Official Closure of IDE for VNS Therapy in TRD
   • Letter from Cyberonics requesting TRD IDE closure
   • Letter from FDA approving TRD IDE closure

Current Labeling

• E-Labeling (link to TRD Physician's and Patient's Manuals in Cyberonics' E-Labeling System)

Bibliography

• Bibliography (0.1 MB)

Payor Communications

1. Blue Cross Blue Shield Technology Evaluation Committee (BCBS TEC)
• June 2005 BCBS TEC Assessment Posted on the BCBS TEC Website in August 2005
• Cyberonics' written response dated 10/3/2005 to the June 2005 BCBS TEC assessment
• Cover letter from Dr. Richard Rudolph, Cyberonics' Vice President Clinical and Medical Affairs and Chief Medical Officer (1.1 MB)
• Attachment A: Cyberonics' Response and Rebuttal of the June 2005 TEC Assessment (1.6 MB)
• Attachment B: Summary of the "new" information which was not considered in the June 2005 TEC Assessment and which confirms that VNS meets the TEC criteria for the FDA TRD approved indication for use (0.2 MB)
• Cyberonics' response to the TEC representatives' 11/03/2005 conference call questions
• Letter from Robert P. Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer dated 11/22/2005 (1.2 MB)
• Letter to the TEC from Dr. Rudolph and Dr. Leon detailing the adequacy of controls in the VNS Therapy studies (1.8 MB)
2. Patient Letters
   • Letter to Senator Mikulski

Links to the FDA Website

• Advisory Committee Information
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=512
• Approval Order, SS&E, Labeling and Other Consumer Information
  http://www.fda.gov/cdrh/pdf/p970003s050.html