Scientific Advisory Committee on Medical Devices used in the Cardiovascular System (SAC-MDUCS) – March 1st 2019 Agenda

Location: 1600 Scott Street, Holland Cross, Tower B, Room 2048
Date & time: March 1, 2019, 7:30 AM - 4:00 PM

Participants: SAC-MDUCS members, guest speakers, Health Canada employees

7:30-8:00
Refreshments

8:00-8:15
Opening Remarks
Dr. J. Patrick Stewart (Director General, Therapeutic Products Directorate (TPD))

Introduction to Health Canada’s Action Plan on Medical Devices:

David Boudreau (Executive Director, Medical Devices Bureau (MDB), TPD)

Part I: Improve how devices get on the market

1. Increase research by medical professionals and increase patient protection
2. Review evidence requirements and expand scientific expertise

Part II: Strengthen monitoring and follow-up

1. Implement mandatory reporting and expand the Canadian Medical Devices Sentinel Network
2. Establish ability to compel information on medical device safety and effectiveness and expand use of real world evidence
3. Enhance capacity in inspection and enforcement

Part III: Provide more information to Canadians

1. Improve access to medical device clinical data
2. Increase the information on device approvals and publish medical device incident data

Review of the Agenda, Declaration of Affiliations and Interests
Dr. John Ducas (Chair)

8:15-8:20
Summary of how information from previous meeting is being used
Kevin Day (MDB, TPD)

8:20-8:35
Discussion on a Patient Group Representative
Health Canada employees and committee members

8:35-9:30
Question 1: Ascending Aortic Dissection - Treatment
Presenter: Dr. Munir Boodhwani (guest speaker)

9:30-10:55
Question 2: SAP Authorization of Devices for First-in-human or Early Developmental Use
Presenters:

1. Dr. Anita Asgar (committee member)
2. Dr. Eric Wasylenko (guest speaker)

10:55-11:10
Break

11:10-12:30
Question 3: Drug Coated Balloon (DCB) - The Paclitaxel Effect
Presenter: Dr. Thomas L. Forbes (guest speaker)

12:30-1:20
Lunch

1:20-2:20
Question 4: Use of labelling (IFU & Other)
Presenter: Dr. John Ducas

2:20-2:45
Question 5: Acceptable PCT Change in LV vs. RV
Presenter: Dr. Ben Elliott (MDB, TPD)

2:45-3:45
Question 6: HIS Bundle Pacing
Presenter: Dr. Raymond Yee (committee member)

3:45-4:00
Next Steps, Closing Remarks and Adjournment of Meeting
Dr. John Ducas