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Cook Zenith

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... Packaging and Sterilization Lisa Kennell Bioresearch Monitoring Rachel Solomon Manufacturing/QSR John Glass/Kent Berthold Patient Labeling ... – PowerPoint PPT presentation

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Title: Cook Zenith


1
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2
Cook Zenith AAA Endovascular Graft and the HL-B
One-Shot? Introduction SystemP020018 April 10,
2003 FDA Circulatory System Devices Panel
MeetingGaithersburg, MD
3
FDA Review Summary
  • Dorothy B. Abel and A. Doyle Gantt
  • DCD/PVDB

4
FDA Review Team
  • Lead A. Doyle Gantt and Dorothy Abel
  • Clinical Paul Chandeysson, M.D.
  • Statistical Gary Kamer
  • In Vivo Animal Studies John Karanian,
    Ph.D.
  • In Vitro Graft Mechanical Testing Terry
    Woods, Ph.D.
  • In Vitro Graft Corrosion Testing Stan
    Brown, D.Eng.
  • In Vitro Delivery System Kachi Enyinna

5
FDA Review Team, cont.
  • Biocompatibility, Packaging and
    Sterilization Lisa Kennell
  • Bioresearch Monitoring Rachel Solomon
  • Manufacturing/QSR John Glass/Kent
    Berthold
  • Patient Labeling Walter Scott, Ph.D.

6
Zenith Components
7
Unique Aspects of this PMA
  • This device utilizes supra-renal fixation,
    whereas other approved endovascular grafts are
    implanted infra-renal.
  • There are various configurations as well as
    multiple sizes in the product line (94
    components).
  • The device is indicated for isolated iliac
    aneurysms (i.e., in addition to abdominal aortic
    aneurysms, with and without iliac involvement).
  • There have been device integrity issues
    identified in pre-clinical and clinical
    evaluations.

8
US Clinical Study
  • IDE G990135
  • 15 centers
  • 52 patients in Phase I (roll-in patients)
  • 200 standard-risk patients in Phase II
  • 100 high-risk patients in Phase II
  • 80 patients who met the general inclusion
    criteria for the low risk arm of the study but
    whose arterial anatomy was not suited for
    endovascular treatment were treated surgically as
    a concurrent control

9
Additional Clinical Studies
  • Australasian study
  • 291 patients at 16 clinical centers in Australia
    and New Zealand
  • 24-month follow-up for the US pivotal study
  • US continued access study
  • 193 standard-risk patients
  • 143 high-risk patients
  • 15 additional female, standard-risk patients
  • 14 patients treated under the compassionate use
    and emergency use provisions

10
Additional Clinical Studies, cont.
  • Worldwide marketing experience
  • Western Australia Registry
  • 170 patients who were treated during the
    Australasian study with longer-term follow-up,
    providing some follow-up data out to 6 years
  • Eurostar Registry
  • 828 patients treated at 45 clinical centers in
    Europe
  • ASERNIP-S (Australian Safety and Efficacy
    Register of New Interventional Procedures
    Surgical) Registry
  • 515 patients in a registry conducted by the
    Australian government

11
Clinical Review Synopsis
  • All clarification and additional information
    requested during the review of the clinical data
    have been provided and the review process
    continues.
  • The company will continue to follow patients out
    to 5 years.
  • Data are not available for treatment of isolated
    iliac aneurysms, however, this indication could
    still be considered.

12
Clinical Review Synopsis, cont.
  • No studies have been designed to compare the
    effect of supra-renal versus infra-renal fixation
    on renal function. The data that are available
    do not demonstrate a concern.
  • There is a large amount of clinical data
    available for this device.
  • The clinical and statistical reviews of this PMA
    have been provided to the panel and Dr.
    Chandeysson and Mr. Kamer will present additional
    information.

13
Pre-clinical Review Summary
  • The review of the biocompatibility, in vivo
    animal studies, manufacturing and sterilization
    information (including packaging and shelf-life)
    have been completed and there are no outstanding
    issues regarding these parts of the PMA.
  • Additional information regarding the pre-clinical
    in vitro studies for a device modification has
    been received and the review process is ongoing.

14
Device Integrity
  • In order to fully characterize the potential for
    problems with device integrity over time and any
    associated clinical implications, the sponsor was
    asked to clearly describe and analyze all
    available data related to device integrity.
  • This included bench testing, animal data,
    clinical data and explant analyses to evaluate
    corrosion, stent fracture, barb separation,
    suture breaks and graft material wear.

15
Device Integrity, cont.
  • The sponsors presentations have appropriately
    described the information available to assess
    device integrity.
  • The descriptions and analyses regarding device
    integrity have been provided to the panel.

16
Device Integrity Summary
  • There have been no clinical sequelae associated
    with corrosion, stent fracture, and single-barb
    and double-barb separations
  • there is a potential for solder loss due to
    corrosion, however, the loss in solder is not
    anticipated to be greater than 50 over 10 years
    and there is a redundancy in design intended to
    provide additional protection from migration as a
    result of barb slippage due to solder loss

17
Device Integrity Summary, cont.
  • stents are not expected to fracture under normal
    conditions, when the device is used in accordance
    with the IFU
  • barb separations are an anticipated event for
    this device, however, the barb design is
    considered by the sponsor to be adequate under
    normal clinical conditions and there is a
    redundancy in design intended to provide
    additional protection from migration as a result
    of barb separation

18
Device Integrity Summary, cont.
  • suture breaks resulting in suprarenal stent
    detachment have been reported in 5 cases
    world-wide and the device has been modified in an
    attempt to address this issue
  • graft material wear has not been observed to be a
    clinical problem
  • appropriate patient selection may reduce the risk
    of device integrity problems and

19
Device Integrity Summary, cont.
  • periodic imaging follow-up is necessary for
    identification of device integrity issues and any
    potentially associated complications to allow for
    timely intervention to avoid serious clinical
    sequelae.

20
Design Changes
  • Flexibility in the bifurcated region had been
    increased to reduce the likelihood of stent
    fracture
  • the number, positioning and method of attachment
    to the stent of the barbs on the suprarenal stent
    have been modified to reduce the likelihood of
    migration
  • stents are now attached to the outside of the
    graft instead of the inside to reduce graft wear
    and to make a smooth inner lumen and

21
Design Changes, cont.
  • the number of sutures holding the components of
    the device together have been increased to
    minimize the potential for separation of the
    suprarenal stent.

22
Device Integrity Review Synopsis
  • There is extensive clinical information available
    for the Zenith Endovascular Graft.
  • The reports of device integrity observations are
    complete.
  • Although some devices will have integrity
    problems after implantation, adequate information
    has been provided to define the risk and to allow
    for a determination regarding safety and
    effectiveness.

23
Conclusions
  • All FDA requests for additional information have
    been satisfied.
  • The issues identified by the review team as
    warranting discussion are outlined in the
    questions for the panel.
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