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UNITED STATES OF AMERICA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
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MEDICAL DEVICES ADVISORY COMMITTEE
ORTHOPEDIC AND REHABILITATION DEVICES PANEL
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Thursday, February 22, 2007
The meeting came to order at 8:00 a.m. in the Grand Ballroom of the Hilton Washington DC North, 206 Perry Parkway, Gaithersburg, MD. Dr. Jay D. Mabrey, Chairman, presiding.
JAY D. MABREY, MD, ACTING CHAIRPERSON
CONNIE F. WHITTINGTON, MSN, RN, ONC, CONSUMER
PAMELA W. ADAMS, MS, RAC, CQM, INDUSTRY
MICHAEL B. MAYOR, MD, DEPUTIZED VOTING MEMBER
SANJIV H. NAIDU, MD, PHD, DEPUTIZED VOTING MEMBER
SHARON-LISE T. NORMAND, PHD, DEPUTIZED VOTING MEMBER
KATHLEEN J. PROPERT, SCD, DEPUTIZED VOTING MEMBER
HARRY B SKINNER, MD, PHD, DEPUTIZED VOTING MEMBER
RONALD P. JEAN, PHD, EXECUTIVE SECRETARY
MARK N. MELKERSON, MS, FDA REPRESENTATIVE
A G E N D A
CALL TO ORDER 3
CONFLICT OF INTEREST AND DEPUTIZATION TO VOTING
MEMBER STATUS STATEMENTS
UPDATE SINCE THE SEPTEMBER 19, 2006 MEETING
FIRST OPEN PUBLIC HEARING 15
SPONSOR PRESENTATION 41
FDA PRESENTATION 105
PANEL DELIBERATIONS 136
PANEL DELIBERATIONS AND FDA QUESTIONS 184
SECOND OPEN PUBLIC HEARING 267
FDA AND SPONSOR SUMMATIONS 269
PANEL VOTE 270
EXEC. SEC. JEAN: Good morning, ladies and gentlemen. We are ready to begin this meeting of the Orthopedic and Rehabilitation Devices Panel. I am Ronald Jean, the Executive Secretary of this panel, and a Scientific Reviewer in the Division of General Restorative and Neurological Devices.
If you haven't already done so, please sign the attendance sheets that are on the tables by the doors. Information on today's agenda and for panel meeting minutes and transcripts is at these tables. Upcoming panel meetings are announced on our Advisory Panel website, and in the Federal Register. Please monitor the panel website for future meeting announcements. Finally, as a courtesy to others in the room, please silence your cell phones during the meeting. Thank you.
I will now read into the record two agency statements prepared for this meeting, the Appointment of Temporary Voting Members Statement, and the Conflict of Interest Statement. This is the Appointment to Temporary Voting Status. "Pursuant to the authority granted under the Medical Devices Advisory Committee Charter dated October 27th, 1990, and amended April 20th, 1995, I appoint the following as voting members of the Orthopedic and Rehabilitation Devices Panel for the duration of this meeting on February 22nd, 2007; Michael B. Mayor, M.D.; Sanjiv H. Naidu, M.D., Ph.D.; Sharon-Lise T. Normand, Ph.D.; Kathleen J. Propert, Sc.D.; Harry B. Skinner, M.D., Ph.D. For the record, these people are special government employees and are consultants to this panel, or another panel under the Medical Devices Advisory Committee. They have undergone the customary conflict of interest review, and have reviewed the material to be considered at this meeting. I also appoint Jay D. Mabrey, M.D., as the Acting Panel Chair for the duration of this meeting." Signed by Daniel G. Schultz, M.D., Director, Center for Devices and Radiological Health, dated on February 8th, 2007.
I will now read the FDA Conflict of Interest Disclosure Statement. "The Food and Drug Administration is convening today's meeting of the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee under the authority of the Federal Advisory Committee Act of 1972. With the exception of the Industry Representative, all members and consultants of the panel are special government employees, or regular federal employees from other agencies, and are subject to federal conflict of interest laws and regulations. The following information on the status of this panel's compliance with federal ethics and conflict of interest laws covered by, but not limited to, those found at 18 USC Section 208, are being provided to participants in today's meeting, and to the public. FDA has determined that members and consultants of this panel are in compliance with federal ethics and conflict of interest laws.
Under 18 USC Section 208, Congress has authorized FDA to grant waivers to special government employees who have financial conflicts when it is determined that the agency's need for a particular individual's services outweighs his or her potential financial conflict of interest. Members and consultants of this panel who are special government employees have been screened for potential financial conflicts of interest of their own, as well as those imputed to them, including those of their employer, spouse, or minor child related to the discussions of today's meeting. These interests may include investments, consulting, expert witness testimony, contracts, grants, CRADAs, teaching, speaking, writing, patents and royalties, and primary employment.
Today's agenda involves the review of a pre-market approval application for the Cormet 2000 Hip Resurfacing System sponsored by Corin USA. This system is intended for use in resurfacing hip arthroplasty for reduction or relieve of pain, and/or improved hip function in skeletally mature patients with non-inflammatory degenerative arthritis, or inflammatory arthritis. This is a particular matters meeting during which specific matters related to the PMA will be discussed.
Based on the agenda for today's meeting and all financial interests reported by the panel members and consultants, a Conflict of Interest waiver has been issued in accordance with 18 USC Section 208(b)(3) to Dr. Michael Mayor. His waiver involves a patent license to a sister company of a competitor. He receives less than $15,001 in royalties for the patent which is unrelated to today's agenda. This waiver allows this individual to participate fully in today's deliberations. A copy of this waiver may be obtained by visiting the agency's website at www.fda.gov/ohrms/dockets/default.htm, or by submitting a written request to the agency's Freedom of Information office, Room 630 of the Parklawn Building. A copy of this statement will be available for review at the registration table during this meeting, and will be included as part of the official transcript.
Pamela Adams is serving as the Industry Representative acting on behalf of all related industry and is employed by Etex Corporation, Inc. We would like to remind members and consultants that if the discussions involve any other products or firms not already on the agenda, for which an FDA participant has a personal or imputed financial interest, the participants need to exclude themselves from such involvement, and their exclusion will be noted for the record. FDA encourages all other participants to advise the panel of any financial relationships that they may have with any firms at issue." Thank you.
It is my pleasure to announce that Dr. Jay Mabrey will be the new Chairperson of the Orthopedic and Rehabilitation Devices Panel. In addition, Dr. Kathleen Propert will be appointed a Voting Member. I would now like to turn the meeting over to our Chairperson, Dr. Jay Mabrey.
CHAIR MABREY: Good morning. My name is Dr. Jay Mabrey, and I am the Chairperson of the Orthopedic and Rehabilitation Devices Panel. I am the Chief of Orthopedics at Baylor University Medical Center in Dallas. My practice focuses on adult reconstruction of the hip and knee.
At this meeting, the panel will be making a recommendation to the Food and Drug Administration on the approvability of pre-market approval application P050016 for the Corin Cormet 2000 Hip Resurfacing System. This device is intended for use in resurfacing hip arthroplasty for reduction or relief of pain, and/or improved hip function in skeletally mature patients with non-inflammatory degenerative arthritis, or inflammatory arthritis.
Before we begin, I would like to ask our distinguished panel members, who are generously giving their time to help the FDA in the matter being discussed today, and other FDA staff seated at the table to introduce themselves. I would ask that you state your name, your area of expertise, your position, and your affiliation. And I'll begin with Ms. Adams.
MS. ADAMS: Pamela Adams. I'm serving as the Industry Representative to this panel. I'm employed by Etex Corporation, and I have over 20 years of experience in the medical device industry.
MS. WHITTINGTON: I'm Connie Whittington. I sit as the Consumer Representative on this panel. I am the Director of Nursing Systems at Piedmont Hospital in Atlanta, Georgia. I have 35 years experience in orthopedics, with most of those being in joint replacement.
DR. MAYOR: Michael Mayor from the Dartmouth Hitchcock Medical Center in Hanover, New Hampshire, Professor of Orthopedics at the Dartmouth Medical School. My practice concentrated on hip and knee reconstruction, and hip and knee arthroscopy, and I'm a past Chairman of the panel.
DR. PROPERT: I'm Kathleen Propert, Professor of Biostatistics at the University of Pennsylvania, and my area of expertise is in clinical trials.
DR. NAIDU: My name is Sanjiv Naidu. I'm a Professor of Orthopedic Surgery and Engineering Science Mechanics at Penn State.
DR. NORMAND: Good morning. My name is Sharon-Lise Normand. I am a Professor of Healthcare Policy and Biostatistics in the Department of Healthcare Policy Harvard Medical School, and the Department of Biostatistics of Harvard School of Public Health, Statistician with expertise in the area of medical devices, Bayesian inference, and observational studies.
DR. SKINNER: My name is Harry Skinner. I'm Professor of Orthopedic Surgery at the University of California Irvine, also Professor of Mechanical and Aerospace Engineering at the University of California Irvine. My area of interest is joint replacement, and I'm a hip and knee surgeon, primarily.
MR. MELKERSON: I'm Mark Melkerson. I'm the Division Director for the Division of General Restorative and Neurological Devices.
CHAIR MABREY: I would like to note for the record that the voting members present constitute a quorum, as required by 21 CFR Part 14. I would also like to add that the panel here today before you has received training in FDA device law and regulations. There will be a brief presentation before the main agenda topic. Dr. Jonette Foy will give us an orthopedic update since the September 19th, 2006 panel meeting.
DR. FOY: Good morning. As Dr. Mabrey just indicated, this is going to be a brief update from the update that was provided in our September panel. The following topics will be briefly touched upon. The upcoming panel meeting dates that we tentatively have scheduled are listed as March 27th and 28th, 2007, and May 22nd and 23rd, 2007. As Dr. Jean previously indicated, please be on the lookout for FR notices.
This is an update from the previous slide that we presented in September. I wanted to draw your attention to the top three items listed here. There are several items that are currently under review, or have recently had FR notices published on them. The first one we have listed here is a reclassification petition for bone heterograft, the second being the exemption petition for cranial orthoses, and the third being a reclassification petition for non-invasive bone growth stimulators.
I wanted to briefly give you an update regarding guidance documents. We do have several that are currently in the works for the orthopedic venue, the interbody fusion guidance, cartilage guidance, artificial disk guidance, femoral stem guidance, and an OPC guidance for hip stems. And I also wanted to draw your attention to some general guidance documents which are currently in the works. The sterility guidance document, because it will potentially have bearing on the orthopedic arena, so please be on the lookout for that document to be posted shortly to the dockets in a draft form for you to provide comment on. And then the post approval studies that have been imposed by PMA order, a guidance document was recently published by our Office of Surveillance and Biometrics.
This is not new, it's just a friendly reminder, that you can use eCopy, which essentially means that you provide an exact duplicate of your pre-market submission in electronic form. It does help facilitate our review, and it does replace one of the paper copies. The information can be found at the following website.
Post approval study panel update. We talked about this in September. Unfortunately, I don't have really any more information to convey to you at this time, but once again, be on the lookout, more information should be coming shortly.
Lastly, some DGRND staffing changes, we have added some staff. We have lost some staff, as well. We have added a toxicologist that's currently going to be serving both the orthopedic branches, as well as a resource for the Division at-whole, Dr. Kadahl. We've also added Deepa Gavina, who is in the spine group, and Dr. Jove Graham, who was previously in OSEL, is now working part-time for the spine branch. Unfortunately, we have had some people leave, some of them not permanently. Ms. Ann Ferriter is currently on a detail to OSB, Nirmal Mishra has retired, and one of the spine members, George Ngatha, has relocated to the plastics group, and as some of you are well aware, Ms. Holly Rhodes recently left to join industry. We have also added a new permanent manager to our staff, Dr. Larry Coyne, who is the Branch Chief for Restorative. And lastly, sort of our plea, that we would like to seek additional participation from individuals outside of the agency, and there's different venues that you can use. You can help us through Advisory Panels, like the members that we have here today, or even if you're interested in employment. And please contact the individuals that are listed here; that would be Dr. Jean for an Advisory Panel, if you're interested in that, or Ms. Pauline Fogarty, if you're interested in other employment opportunities. Thanks so much.
CHAIR MABREY: Thank you, Dr. Foy. We will now proceed with the open public hearing portion of the meeting. Prior to the meeting, only four people asked to speak in the open public hearing. They will speak in the order of their request to speak. We ask that you speak clearly into the microphone, as the transcriptionist is dependent upon this means of providing an accurate record of this meeting. Please state your name, and the nature of any financial interest you may have in this, or in another medical device company.
I would also remind the next four speakers that you are allotted five minutes, and that we will restrict you to those five minutes so that we may remain on schedule, and give the Sponsor their due time. Dr. Jean will now read the Open Public Hearing Statement.
EXEC. SEC. JEAN: "Both the Food and Drug Administration and the Public believe in a transparent process for information gathering and decision making. To ensure such transparency at the open public hearing session of the Advisory Committee meeting, FDA believes that it is important to understand the context of any individual's presentation. For this reason, FDA encourages you, the open public hearing or industry speaker, at the beginning of your written or oral statement, to advise the committee of any financial relationship that you may have with the Sponsor, its product, and if known, its direct competitors. For example, this financial information may include the Sponsor's payment of your travel, lodging, or other expenses in connection with your attendance at the meeting. Likewise, FDA encourages you at the beginning of your statement to advise the committee if you do not have any such financial relationships. If you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking."
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