Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System (SAC-MDUCS) 

Agenda

Location: 1600 Scott Street, Holland Cross, Tower B, Room 2048
Date & Time: January 24, 2020, 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
David Boudreau (A/Director General, Medical Devices Directorate (MDD))

8:15-8:30

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

8:30-8:40

Summary of Previous Advice Used & General Considerations for Today's Meeting
Kevin Day (MDD)

8:40-9:10

#1: Overview of Clinical Outcomes Associated with Paclitaxel Coated Devices Used for the Treatment of Peripheral Arterial Disease (PAD)  
Presenter:
Dr. Ian Aldous (MDD)

9:10-10:00

#2: Current Clinical Practice in the Use of Paclitaxel Coated Devices for the Treatment of PAD
Guest Speaker: Dr. Thomas L. Forbes

10:00-10:15

Break

10:15-11:00

#3: Patient Benefits Associated with the Use of Drug-coated Balloons and Plain Old Balloon Angioplasty (POBA) in Above-the-knee PAD
Guest Speaker: Dr. Ahmed Kayssi

11:00-11:50 

#4: Clinical Expert opinion on appropriate Indications For Use and labelling requirements for Paclitaxel Coated Balloons in the treatment of above-the-knee PAD
Guest Speaker: Dr. Sudhir Nagpal

11:50-1:00

Lunch

1:00-1:40

#5: Patient Perspective, Patient Preference, Informed Consent 
Presenter: Dr. Jillianne Code

1:40-2:20

#6: Pre-market new license and amended license requirements
Presenters:  
Dr. Karen Kennedy (MDD)
Dr. Ben Elliott (MDD)

2:20-3:30

#7 Requirements for non-Superficial Femoral Artery (SFA) use of Drug Coated Balloon (DCB)/Drug Eluting Stent (DES)
Presenter: Chris Schmidt (MDD)
Guest Speaker: Dr. Dheeraj K. Rajan

3:30-3:45 

#8 What Health Canada has heard and Wrap-up
Kevin Day (MDD)

3:45-4:00

Next Steps, Closing Remarks and Adjournment of Meeting
Dr. John Ducas (Chair)