Heart health
New drugs
Brinavess
(new active substance)
Medical ingredient:
Vernakalant Hydrochloride
Indication:
Brinavess is for the treatment of a fast, irregular heart rate called atrial fibrillation.
For more information, see the Regulatory Decision Summary.
New generic drugs
Health Canada approved 33 new generic drugs for heart health.
New medical devices
CardioMEMS HF SystemP
(novel technology)
Indication:
A medical device used for wirelessly measuring and monitoring pulmonary artery pressure in New York Heart Association Class III heart failure patients who have been hospitalized for heart failure in the previous year. Changes in pulmonary artery pressure can be an effective early predictive measure of worsening heart failure.
For more information, see the Regulatory Decision Summary.
Impella RP Circulatory Support System
(novel technology)
Indication:
A medical device providing circulatory assistance for up to 14 days in adult patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
For more information, see the Regulatory Decision Summary.
Risk communications
Health Canada released three risk communications for heart health.