QUESTIONS FOR PANEL

1
QUESTIONS FOR PANEL
2
Evaluation of Trial Design

1. Please discuss whether there is reasonable
   assurance that the results from UMC can be
   generalized to all transplant centers.

3
Evaluation of Safety

1. Please discuss whether the safety parameter
   results of the clinical trial provide reasonable
   assurance of safety in the intended population.
   Accordingly, does any class of adverse events
   (i.e. Infection, Bleeding, or Neurological Event)
   raise concerns in comparison with what would be
   acceptable for a ventricular assist device in
   bridge-to-transplant patients. If so, what
   warning should be included in the labeling?

4
Evaluation of Effectiveness

• The Agency has assumed that a 65 survival is a
  reasonable goal for a left ventricular assist
  device. It is assumed that BiVAD patients are
  on average at least as sick as LVAD patients,
  therefore 65 survival would be a reasonable goal
  for BiVADS.
• Please indicate whether you agree with the
  Agencys goal of 65 survival for BiVAD
  patients.
• Please discuss whether you believe that the
  CardioWest TAH is efficacious as a
  bridge-to-transplant device for patients with
  biventricular failure.

5
Evaluation of Effectiveness

1. Please comment on the decision-making (for these
   types of heart failure patients) for choosing
   between a total support device vs. an LVAD.
   Please discuss whether it is reasonably assured
   that the patients were in need of a total support
   device.

6
Labeling

• In regards to the indications for use, labeling,
  and clinical experience, please comment on the
  following
• Do the indications for use adequately define the
  patient population studied and for which the
  device will be marketed?
• Does the labeling adequately define BiVAD
  patients as opposed to LVAD patients?
• Are there any additional warning, precautions, or
  contraindications that you think should be
  included in the labeling to assist practitioners
  in determining the need for biventricular support?

7
Training

1. Please comment on the adequacy of the proposed
   physician training plan, as described in the
   panel package (Section 7 of the Clinical Summary)

8
Post-Market Approval Study

1. Based on the clinical data provided in the panel
   pack, please comment on the design of the
   postmarket approval study. Do you agree that the
   patients should be followed for 1 year post
   transplant with data collection for adverse
   events?