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Scientific Advisory Committee on Medical Devices used in Cardiovascular System - Agenda - December 10, 2010

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Agenda

Place: Holland Cross, Tower B, Paradigm Room
Date and Time: December 10, 2010 8:00 to 4:00
Participants: SAC MDUCS members, Health Canada
Science Advisor: Hripsime Shahbazian
Scientific and Regulatory Officer: Larissa Lefebvre
Chairperson: Dr. Ducas

07:30-08:00

Refreshments

08:00-08:15

Opening remarks
Review of the Agenda, Declarations of affiliations and interests

08:15-08:45

Summary of how the information from previous meetings is being used
Kevin Day (Medical Device Bureau)

08:45-10:00

Question 1: Electrophysiology - Introduction of sensors into cardiac resynchronization Therapy (CRT) devices for the treatment and optimization of Heart Failure treatment
Dr. Mitchell

10:30-10:15

Break

10:15-11:15

Question 2: Drug eluting balloons (DEB)
Guest speaker - Dr. Olivier Bertrand

11:15-12:00

Question 3: Overview of the Special Access Program (SAP)
Kevin Day

12:00-1:00

Lunch

1:00-2:00

Question 4: "Sutureless" aortic valves
Dr. Menkis

2:00-3:00

Question 5: Human factor issues related to cardiovascular medical devices
Dr. Ducas

3:00-3:45

Question 6: Overview of recall procedures
Marketed Health Products Directorate, Health Products and Food Branch Inspectorate and Medical Devices Bureau

3:45-4:00

Next steps, Closing Remarks and Adjournment of Meeting