Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System – Announcement of Meeting – March 1, 2019

Ottawa, Ontario
February 1, 2019

The purpose of this Notice is to announce an upcoming meeting of Health Canada's Scientific Advisory Committee on Medical Devices used in the Cardiovascular System (SAC-MDUCS).

The advice received from this meeting will be used to facilitate and enhance the review process for medical devices that are used in the cardiovascular system.

Mandate of the SAC-MDUCS

To provide Health Canada with ongoing and timely scientific, technical, medical and clinical advice on current and emerging issues pertaining to the evaluation of safety and effectiveness of devices used in the cardiovascular system.

For more details on the mandate of the SAC-MDUCS, please refer to the Terms of Reference of the SAC-MDUCS.

Meeting Format

Subject matter experts will make presentations to the Committee in the context of the questions posed by Health Canada.

Upon completion of the presentation and following discussion, the Committee will deliberate before providing recommendations to Health Canada.

Agenda

The following topics will be discussed: Ascending Aortic Dissection treatment techniques; Special Access Program (SAP) authorization of devices for first-in-human or early developmental use; drug-coated balloons and the paclitaxel effect; use of Informed Consent Form labelling, acceptable Pacing Capture Threshold (PCT) change in left vs. right ventricle; and the oversight of medical devices that stimulate the Bundle of His.

A more detailed agenda will be posted in the coming weeks.