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FOOD AND DRUG ADMINISTRATION


NATIONAL INSTITUTES OF HEALTH


Meeting of:


CIRCULATORY SYSTEM


DEVICES PANEL





June 23, 1999


Gaithersburg Hilton

Gaithersburg

Maryland


Reported By:


CASET Associates

10201 Lee Highway, Suite 160

Fairfax, Virginia 22030

(703) 352-009

TABLE OF CONTENTS


Page


Call to Order - Dr. Curtis 1


Conflict of Interest Statement - Dr. Stuhlmuller 1


Open Public Hearing 5

- Anthony D. Whittemore, MD 5

- John A. Mannick, MD 8


PREMARKET APPROVAL APPLICATION P990017


Company Presentation 12


FDA Presentation 58


Panel Discussion 66


Open Public Hearing 190

Patricia Cole


Panel Deliberations and Vote 191


Premarket Approval Application P990020


Company Presentation 204


FDA Presentation 245


Panel Discussion 252


Panel Deliberation and Vote 300



PARTICIPANTS


ANNE B. CURTIS, MD, Chairperson. University of Florida


JOHN E. STUHLMULLER, MD, Executive Secretary. Food and Drug Administration


VOTING MEMBERS:


MICHAEL D. CRITTENDEN, MD, Harvard University


FRANCIS R. GILLIAM, III, MD, Virginia Cardiovascular Specialists


RENEE S. HARTZ, MD, Tulane Medical Center


GULSHAN K. SETHI, MD, University of Arizona


TONY W. SIMMONS, MD, Bowman-Gray School of Medicine


CONSULTANTS APPOINTED TO TEMPORARY VOTING STATUS:


KENT R. BAILEY, PhD, Mayo Clinic


JAMES A. DEWEESE, MD, University of Rochester


MICHAEL J. PENTECOST, MD, Georgetown University Medical Center


BRUCE A. PERLER, MD, Johns Hopkins University


ANNE C. ROBERTS, MC, University of California at San Diego


INDUSTRY REPRESENTATIVE

GARY JARVIS, St. Jude Medical


CONSUMER REPRESENTATIVE:

Robert A. Dacey, Longmont, Colorado


FOOD AND DRUG ADMINISTRATION:

THOMAS J. CALLAHAN, PhD

BETTE L. LEMPERLE, RN, BSN, MPH

MEGAN MOYNAHAN, MS

CATHERINE P. WENTZ, MS

PAUL L. CHANDEYSSON, MD

JOHN DAWSON, MS, JD

GARY KAMER, MS


P R O C E E D I N G S (8:03 a.m.)

AGENDA ITEM: Call to Order.

DR. CURTIS: I am going to call this meeting of the circulatory system devices panel to order.

The first order of business will be the reading of the conflict of interest statement by Dr. Stuhlmuller.

AGENDA ITEM: Conflict of Interest Statement.

DR. STUHLMULLER: The following announcement addresses conflict of interest issues associated with this meeting, and is made part of the record to preclude even the appearance of an impropriety.

To determine if any conflict exists, the agency reviewed the submitted agenda for this meeting and all financial interests reported by the committee participants.

The conflict of interest statutes prohibit special government employees from participating in matters that could affect them or their employer's financial interests.

However, the agency has determined that participation of certain members and consultants, the need for whose services outweigh the potential conflict of interest involved, is in the best interests of the government.

Therefore, waivers have been granted for Drs. Hartz and Perler for their interest in firms that could potentially be affected by the panel's recommendations.

Copies of these waivers may be obtained from the agency's Freedom of Information Office, Room 12A-15 of the Parklawn Building.

We would like to note for the record that the agency took into consideration other matters regarding Drs. Curtis, Crittenden, Pentecost, Roberts and DeWeese.

Each of these panelists reported interests in firms at issues, but in matters that are not related to today's agenda, or that involve no financial interest.

The agency has determined, therefore, that they may participate fully in all discussions.

In the event that discussions involve any other products or firms not already on the agenda, for which an FDA participant has a financial interest, the participant should excuse him or herself from such involvement, and the exclusion will be noted for the record.

With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firms whose products they may wish to comment upon.

Appointment to temporary voting status. Pursuant to the authority granted under the medical devices advisory committee charter dated October 27, 1990, as amended April 20, 1995, I appoint the following people as voting members of the circulatory system devices panel for this meeting on June 23, 1999.

Drs. Bailey, Deweese, Pentecost, Perler and Roberts. For the record, these people are special government employees, and are consultants to this 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.

It is signed David W. Feigel, Jr., MD, director, Center for Devices and Radiological Health, dated 6-21-99.

DR. CURTIS: What I would like to do next is have all the members introduce themselves. I am Anne Curtis. I am from the University of Florida and I am an electrophysiologist there. We can start over here.

MR. JARVIS: Gary Jarvis, industry representative.

MR. DACEY: Robert Dacey, consumer representative.

DR. SETHI: Gulshan Sethi from the University of Arizona, Tucson, cardiac surgery.

DR. PENTECOST: Michael Pentecost, intervention radiologist at Georgetown University.

DR. DE WEESE: Jim DeWeese, cardiac and vascular surgeon emeritus, University of Rochester.

DR. ROBERTS: Anne Roberts, University of California, San Diego, interventional radiologist.

DR. STUHLMULLER: John Stuhlmuller, medical officer and executive secretary for the panel, with FDA.

DR. SIMMONS: Tony Simmons, Wake Forest University. I am a cardiac electrophysiologist.

DR. HARTZ: Renee Hartz, cardiac surgeon, Tulane University.

DR. GILLIAM: Roosevelt Gilliam with Virginia Cardiovascular Specialists. I am a cardiac electrophysiologist.

DR. BAILEY: Kent Bailey, biostatistician, Mayo Clinic.

DR. CRITTENDEN: Michael Crittenden, cardiac surgeon, West Roxbury VA, Harvard University.

DR. PERLER: Bruce Perler, vascular surgeon, Johns Hopkins.

DR. SAPIRSTEIN: Wolf Sapirstein. I am an associate director of this division of cardiovascular and circulatory devices, and standing in for Dr. Callahan, who is ill.

DR. CURTIS: There is no old business that we need to go over today.

In terms of new business, we have two members of the panel who have completed their terms as voting members. We would like to recognize them today, with a certificate and a plaque.

We have one for Dr. Gulshan Sethi. (Certificate and plaque awarded.) We also have a certificate and a plaque for Dr. Rosie Gilliam. (Certificate and plaque awarded.)

We will move on now to the open public hearing. There are two speakers who have requested time today. Public speakers are allowed only a 10-minute limit for any comments they would like to make.

AGENDA ITEM: Open Public Hearing.

DR. CURTIS: Our first public speaker is Dr. Anthony Whittemore from the Society for Vascular Surgery. Dr. Whittemore?

STATEMENT OF ANTHONY D. WHITTEMORE, MD, Immediate Past President, North American Chapter, International Society for Vascular Surgery.

DR. WHITTEMORE: Madam Chairperson, members of the panel, my name is Andy Whittemore. My remarks will be brief. I have no slides.

I am the chief medical officer at the Brigham and Women's Hospital in Boston. I am also the chair of vascular surgery at the same institution. I am professor of surgery at Harvard Medical School.

I am here on behalf of the joint societies, representing the Society for Vascular Surgery and, as its immediate past president, the North American Chapter of the ISCVS as well.

Before I go much further, you should know that I have implanted several of these devices in my own patients at our institution, neither of which are under consideration today.

I have no vested interest in either of these devices, or them as well.

The societies have carefully monitored the development of these devices over the years, and the use of endovascular grafts for the treatment of abdominal aortic and aorto-ileac aneurysms.

In the hands of properly trained and qualified individuals, the use of these grafts appears to be safe, at least in the short term, and efficacious.

However, the long-term efficacy is unknown and careful monitoring of patients who receive this therapy will be essential.

If you decide to recommend approval of the devices under consideration today, we would urge you to include, as part of your recommendation, a requirement that two specific conditions be met.

First, the use of any device should be limited to physicians who have received specialized training in the use of that specific device.

The surgical techniques and skills that are required to safely and appropriately implant these devices vary from one device to another, such that training in one is not readily transferrable to the use of another. This training ought to be provided at industry expense.

Our second condition states that all procedures performed with endovascular grafts should be entered in some kind of national data registry.

In order to properly monitor and evaluate long-term efficacy of these devices, it is essential that all procedures be consistently and uniformly reported to a single location, such as the registry recently established by our Lifeline Foundation.

A national registry will serve as a rich source of information that will better enable us to answer critical questions regarding the long-term safety and efficacy of this very promising and emerging new technology.

Hopefully, you will agree with us and include these conditions in your recommendations to the agency. We believe they are in the best interests of the patients, as well as manufacturers and physicians, and that their adoption will assure that the devices will be used only by fully-trained and qualified physicians, and that information regarding long-term efficacy will become readily available.

The societies appreciate the opportunity to appear before the panel. Thank you.

DR. CURTIS: A second speaker is Dr. John Mannick from the Lifeline Foundation.

PRESENTATION OF JOHN MANNICK, MD, President, Lifeline Foundation.

DR. MANNICK: Madam Chairman, ladies and gentlemen, my name is John Mannick. I am a professor of surgery at Harvard Medical School and the president of the Lifeline Foundation.

I have no relationship with any of the manufacturers of any of the devices under consideration today.

The Lifeline Foundation, to describe it, is a not-for-profit charitable organizations, established in 1987 under the sponsorship of the two vascular societies, that you have just heard about from Dr. Whittemore -- in other words, the Society for Vascular Surgery and the North American Chapter of the International Society for Cardiovascular Surgery. They are the two sponsoring organizations for the foundation.

As a 501(c)(3) organization under the IRS regulations, the foundation is supported by contributions from individual members of the two vascular societies, corporate sponsors, private foundations whose priorities include medical research, and by individual donors from the lay public.

The foundation, as Dr. Whittemore has already told you, contracted to set up a registry for endovascular grafts used to repair aortic aneurysms.

The foundation is contracted with the New England Research Institutes, for professional services in connection with the development and monitoring of the data in this registry, and for following up the patients who undergo abdominal aortic aneurysm repair with an endovascular graft.

This initiative represents, we think, an important collaboration between device manufacturers, clinical investigators and other scientists, and will be facilitated by representatives of National Heart, Lung and Blood Institute and the FDA.

The registry proposal includes some important scientific and collaborative precedents. Scientifically, this registry will extend the follow-up of patients currently under short-term investigational trials of these devices, and we will also provide follow-up for patients treated with the same devices, or other devices, after FDA approval.

In other words, we propose to capture all of those who are currently under IDEs and those patients after IDEs, insofar as we are able to do so, and we think we can get most of them, after FDA approval of any devices.

We will have centrally maintained standard protocols for patient follow up, adverse event adjudication and device explant evaluation.

We already have committees in place for adverse events and explain analysis. The adverse events committee is chaired by Dr. DeWeese on this panel.

We will also estimate the survival of patients with different risk profiles, and we will assess the performance of the devices. The end points, of course, the primary end points will be death of the patient from any cause, rupture of the aneurysm and device failure.

We also hope to identify further appropriate studies from analyzing the registry analysis.

Collaboratively, the registry reflects the combined input of clinical investigators, all 10 manufacturers of the devices under consideration today, those who have devices in trial and those proposed to do so, all of whom have decided to sponsor this registry with us.

I think we have everyone on board who has anything to do with making or proposing to make such devices.

We hope that this surveillance will advance scientific knowledge with respect to the benefit to patients of this type of vascular device which we believe probably has the potential for considerably broader application in the future.

Now only have the manufacturers provided a standard minimum data set from their respective investigational trials and developed, for the first time, a standard explant protocol to be adopted by the industry, they are also committed to fiscal support of this initiative through the Lifeline Foundation, in a hands-off fashion.

So, we believe this registry, in summary, will be an important way to learn what happens in the long run to these devices once they are approved by the FDA, and we will also be able to follow, in the long-term, those patients already under surveillance under IDEs. Thank you very much.

DR. CURTIS: Are there any unscheduled speakers who want to come forward at this time? There will be a second short public hearing later on, near the end of the discussion on the first PMA.

If not, before we get started with the first PMA, I would like to remind the panel about the guidelines for reviewing two PMAs for similar devices with similar indications, because that is what we are going to be doing today.

Each PMA must stand on its own. So, the clinical evaluation of the safety and effectiveness of each device must be made using the clinical data contained with each PMA based on its intended use.

The evaluation of safety and effectiveness for each device cannot be made based on comparison of clinical data relating one device to the other.

So, these are two separate PMAs. We have to consider them separately, and we should not be discussing data from one at the other hearing later today.

Let's now move on to premarket approval application P990017, Guidant Endovascular Technologies, the EBT Abdominal Aortic Tube Bifurcated Endovascular Grafting System, the company's presentation first.

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