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)
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