DHHS / FDA / CDRH 1 Panel Questions-Clinical Trial Design 1.Can the data from the investigator-sponsor studies be considered in the evaluation of high.

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Presentation transcript:

DHHS / FDA / CDRH 1 Panel Questions-Clinical Trial Design 1.Can the data from the investigator-sponsor studies be considered in the evaluation of high risk stenting given the differences in trial conduct for the high-risk investigator-sponsor registries?

DHHS / FDA / CDRH 2 Panel Questions-Clinical Trial Design 2.How does the large enrollment in the registry CAS arm affect interpretation of results?

DHHS / FDA / CDRH 3 Panel Questions-Clinical Trial Design 3.How does premature termination of the pivotal randomized study affect conclusions derived from this study?

DHHS / FDA / CDRH 4 Panel Questions-Safety and Effectiveness 4. Please discuss how data from previous carotid treatment trials (NASCET, ACAS) can be used to analyze the current peri- operative/30-day data set with regard to safety.

DHHS / FDA / CDRH 5 Panel Questions-Safety and Effectiveness 5.There were multiple ways for higher risk patients to be entered into the SAPPHIRE trial. Please discuss the impact of these various patient subgroups on ability to generalize safety and effectiveness results.

DHHS / FDA / CDRH 6 Panel Questions-Safety and Effectiveness 6.Effectiveness of stroke prophylaxis has historically required 2 to 5 years monitoring, with safety outcomes generally assessable within the lesser period of 1 year. Please discuss whether chronic data presented for the OTW configuration in the SAPPHIRE trial provide evidence of sustained effectiveness of CAS in preventing stroke in patients at high risk for CEA.

DHHS / FDA / CDRH 7 Panel Questions-Safety and Effectiveness 7.Is it appropriate for the sponsor to employ OPCs developed from NASCET and ACAS outcomes to assess outcomes for both symptomatic and asymptomatic patients in the SAPPHIRE Trial? Or should the ACAS rates from the asymptomatic trial be used for comparison?

DHHS / FDA / CDRH 8 Panel Questions-Safety and Effectiveness 8.The ACAS and NASCET studies did not include myocardial infarction (MI) as an endpoint. The SAPPHIRE trial included MI as a component of MAE. The distribution of non-Q-wave MI’s are provided under Tab 8 (Addendum) of the Panel Pack. Please comment on the sponsor’s choice of this composite endpoint.

DHHS / FDA / CDRH 9 Panel Questions-Safety and Effectiveness 9.The indications for carotid artery stenting in the registry arm were largely dictated by hazards of surgical exposure. The ability to deploy a stent should not be affected by these criteria. Are outcomes achieved in this registry, i.e., 10% stroke and TIA at 30 days and additional 16% at one year acceptable?

DHHS / FDA / CDRH 10 Panel Questions-Safety and Effectiveness 10.Please comment on whether the incidence of ipsilateral stroke is acceptable.

DHHS / FDA / CDRH 11 Panel Questions-Safety and Effectiveness 12.The various studies employed a total of only four size 5mm stents. Does the Panel believe that there are adequate safety and effectiveness information for this size?

DHHS / FDA / CDRH 12 Panel Questions-Safety and Effectiveness 13.Has the totality of data presented in the carotid stent PMA shown reasonable assurance of safety and effectiveness for the OTW configuration? If not, what niche indications have been shown to be safe and effective for carotid stenting?

DHHS / FDA / CDRH 13 Panel Questions-Labeling 14. Are the indications and contraindications for the OTW configuration clear and supported by the SAPPHIRE study findings? If not, please identify the indication you believe is supported by the sponsor’s data. Specifically, is stenting of asymptomatic patients supported? Should any criteria stipulating when stenting of asymptomatic patients is appropriate be included in the labeling?

DHHS / FDA / CDRH 14 Panel Questions-Labeling 15.Patients with complex atherosclerotic disease of the aorta or highly tortuous carotid arteries are not optimal candidates for carotid stenting. Please comment on the adequacy of the OTW configuration labeling with regard to patients with these anatomic characteristics. If there are candidates that are not optimal that should be added, please also identify them.

DHHS / FDA / CDRH 15 Panel Questions-Labeling 16.Should any other warnings and/or precautions be stipulated in the labeling for the OTW configuration in addition to those found in the proposed labeling?

DHHS / FDA / CDRH 16 Panel Questions-Post-market Study Design 17. Please comment on whether the sponsor’s post approval study plan is adequate. If not, what additional information do you believe should be collected post-approval? Specifically, do you recommend that an independent neurologist make the neurological assessments at each follow-up (currently only proposed for discharge and 30 days)?

DHHS / FDA / CDRH 17 Panel Questions-Training 18.Please comment on whether the sponsor’s training plan is adequate. If not, what additional requirements do you believe should be added to the training program for the OTW configuration?