Bryan® Cervical: FDA 7/17/07, Approvable w/Conditions, Exec.Sum 33 pgs, PPT 157 pgs

[Slackwater]

I generally like Microsoft Powerpoint slides to get rid of extraneous words; show me the data.

I read the Summary first, then the PPT's, however, ... PPT is unfortunately converted to pdf and 150+ pages. Other docs found and lost included a Microsoft Word doc on the FDA site, Xxx pages. The Executive Summary has the clinical results data with tables.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

FDA (Food and Drug Administration)
Center for Devices and Radiological Health

Link Orthopaedic and Rehabilitation Devices Panel - July 17, 2007 (Summary)<UL TYPE=SQUARE>ref: P060023

"The sponsor and FDA presentations focused on pre-clinical testing and clinical data collected on the subject device. Pre-clinical data presented included wear, migration, expulsion and reliability test results. The clinical data were collected in a randomized, multi-center study intended to assess the safety and effectiveness of the Bryan Cervical Disc by demonstrating non-inferiority to a control spinal fusion treatment. Overall success consisted of a composite endpoint including: at least 15 points of improvement on the neck disability index (NDI); maintained/improved neurological status; no serious adverse events related to the surgery/device; and, no additional surgeries classified as a failure. The Bryan Cervical Disc study results were found to be non-inferior to the spinal fusion control out to 24 months.

The Panel voted (7-1-0) to recommend that the PMA application for the Bryan Cervical Disc be found “Approvable with Conditions.” The recommended conditions of approval are summarized as follows:

1. There should be no mention of adjacent level motion or disease in product literature or labeling.

2. A rabbit animal study should be performed on animals confirmed to be free of other conditions (e.g., protozoans), to investigate the effects of particulates on the kidneys.

3. There should be no claim of superiority in the product literature or labeling.

4. There should be appropriate training for surgeons.

5. There should be appropriate patient education materials.

6. The indications for use should be revised to: “The Bryan Cervical Disc is indicated for skeletally mature patients as an alternative for reconstruction following single level surgical decompression for radiculopathy or myelopathy between C3 and C7.”

7. A postapproval study should be conducted out to 10 years, and should analyze effects on adjacent levels, heterotopic ossification and kyphosis. In addition, explant analysis should be conducted with 1 reviewing center.[/list]~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Other FDA Documents:
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~<UL TYPE=SQUARE>Link FDA Executive Summary, P060023, BRYAN Cervical Disc, 7/17/07, 33 pgs

Link Summary Minutes, Medical Devices Advisory Committee, Orthopaedic and Rehabilitation Devices Panel, July 17, 2007, 20 pgs, (90+ KB)

Link BRYAN® Cervical Disc, Orthopaedic and Rehabilitation Devices Advisory Panel Presentation, Medtronic Presenters PPT, July 17, 2007, 157 pgs (5.6 MB)

Link P060023, BRYAN Cervical Disc FDA Presenters PPT, July 17, 2007, 101 pgs (271 KB)[/list]~~~~~~~~~~~~~~~~~~~~~~~~~~
CDRH (Center for Devices and Radiological Health)
Advisory Committees: Orthopaedic and Rehabilitation Devices Panel Link
(I believe CDRH website has transcripts out of order, a mistake, suggest read transcripts in the below order which I deciphered from the URL's, ... )
~~~~~~~~~~~~~~~~~~~~~~~~~~<UL TYPE=SQUARE>
Link Transcript 1 of 4, 100 pgs

Link Transcript 2 of 4, 100 pgs

Link Transcript 3 of 4, 100 pgs

Link Transcript 4 of 4, 128 pgs (~400KB)
[/list]~~~~~~~~~~~~~~~~~~~~~~~~~~

Suggest the above documents, FDA and Medtronic, may/will contain what is in Spine, The Spine Journal, European Spine Journal articles, other meeting abstracts. The Executive Summary includes:

Table 9. Patient accountability based on availability of overall success outcomes
Table 11. Procedure Level
Table 11+. Safety Results Adverse Events Bryan v. ACDF 24 Months
Table 12 Safety results discussed in detail in this section
Table 13. Effectiveness Results
Table 14. Neurologic Results
Table 16. Data contributing to primary analysis of 24-month overall success rate
Table 21. Operative Time and Intraoperative Blood Loss
Table 22. Motion at the Treated Level
Table 23. Angular Motion at Adjacent Levels
Table 24. Analysis of Range of Motion (ROM) for Patients with Radiographic Comments on Osteophytes

In regards to "There should be no mention of adjacent level motion or disease in product literature or labeling", I need to again reference 10+ years of biomechanical studies in-vitro (White, Panjabi, Goel, ..., ..., Finite Element Analysis, and more recently,
<UL TYPE=SQUARE>Orthopaedic Research Society, Transactions Vol.33, San Francisco, CA, 2008
Abstract 1352
Biomechanical Comparison Following Bilevel Fusion, Bilevel Total Disc Replacement and Fusion Plus Total Disc Replacement At Adjacent Levels In Cervical Spine
Ahmad Faizan 1, Vijay K. Goel 1, Nikhil Kulkarni 1, Ashok Biyani 1, Steven Garfin 2, Christopher Bono 3, Paul Maguire 4, Hassan Serhan 4
1 Bioengineering & Orthopedics Surgery, University of Toledo, Toledo, OH;
2 Department of Orthopedics, University of California, San Diego, San Diego, CA;
3 Boston Medical Center, Boston, MA;
4 Depuy Spine, Bethelehem, MA
Link[/list]for making it clear to me as a patient what can happen to adjacent segments. I defer to the FDA viewpoint because we need ten (10) year results, ... Take care, best wishes for patients, ...


Slackwater