On November 20, the Orthopaedics and Rehabilitation Devices Advisory Committee met to discuss and make recommendations for PMA P020033 Independence Technology’s INDEPENDENCE™ iBOT™ 3000 Mobility System intended for individuals who have mobility impairments and the use of at least one upper extremity. The panel recommended approval with 4 conditions main vote (12-0). The conditions were as follows: 1) diagnosis and written prescription order by a physician licensed to practice medicine; 2) user training at the clinician's test site and in the user's home environment; 3) periodic reporting to FDA regarding device failures and injuries; and 4) communication to clinicians of any future device changes (so that the clinicians can adjust their training of prospective users, as necessary).
On November 21, the Orthopaedics and Rehabilitation Devices Advisory Committee met to discuss and make recommendations for PMA P000054 - Wyeth Pharmaceuticals, Inc. InductOs (rhBMP-2/ACS) used to treat fresh tibial fractures. The panel recommended approval with 6 conditions main vote (6-1). The conditions were as follows: 1) Limit the device to the treatment of open long bone fractures that the surgeon believes could benefit from the presence of the BMP; 2) Provide training to the surgeons related to the potential benefit of exposure to osteogenic factors; 3) Include language in the labeling that states that the impact of repeat exposure to the BMP is unknown; 4) Perform 2 post approval studies related to the presence of antibodies to rhMBP-2: Study 1 - natural history study of BMP antibody levels in all patients exposed to rhMBP-2 in any study for any indication/anatomical location and Study 2 - perform a long-term prospective study in animals or humans to address the same long-term antibody level question addressed in study 1; 5) Perform a post approval study to clarify the effectiveness of the device for a subset of fracture types, the details will be determined by FDA and the sponsor; and 6) Perform a statistical evaluation of subjects who received fibula fixation in conjunction with the tibial fixation to determine if this had an impact on effectiveness.
On November 21, the committee had a general spinal discussion regarding the preclinical and clinical information needed for fusion and non-fusion spinal devices.
The committee was formed by the following members:
|Maurean Finnegan M.D.||Nov 20-21||Voting Member|
|Michael Yaszemski M.D., Ph.D.||Nov 20-21||Chairman|
|Sanjiv Naidu M.D., Ph.D.||Nov 20-21||Voting Member|
|Gary Abrams M.D.||Nov 20||Temp Voting Member|
|Richard Friedman M.D.||Nov 20||Voting Member|
|John Kirkpatrick M.D.||Nov 20-21||Voting Member|
|Steve Stiens M.D.
||Nov 20||Temp Voting Member|
|John Doull Ph.D.||Nov 21||Temp Voting Member|
|Ann Buzaid OT||Nov 20||Temp Voting Member|
|Kinley Larntz Ph.D.||Nov 20-21||Voting Member|
|Karen Rue||Nov 20-21||Consumer Representative|
|Kevin McQude PT, Ph.D., MPH||Nov 20||Temp Voting Member|
|Sally Maher ESQ.
||Nov 20||Industry Representative|
|Albert Aboulafia M.D.||Nov 21||Temp Voting Member|
|Blake Hannaford Ph.D.||Nov 20||Temp Voting Member|
|Joel Myklebust Ph.D.||Nov 20||Temp Voting Member|
|Gary Fenical||Nov 20||Temp Voting Member|
|Robert Goldman M.D||Nov 20||Temp Voting Member|
|Robert Herman J.D.||Nov 20||Guest|
|Andrew Schmidt M.D.||Nov 21||Temp Voting Member|
Contact: Hany Demian, Executive Secretary
(301) 594-2036, x184
Transcripts may be purchased form (written requests only):
Miller Reporting Company
735 8th Street, SE
Washington, DC 20003
(202) 546-6666/FAX: 202-546-1502
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500/FAX: 301-332-1726
Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH website: http://www.fda.gov/cdrh/panel/index.html